This section highlights FDA-related milestones and regulatory updates for drugs developed by Biogen (BIIB).
Over the past two years, Biogen has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LEQEMBI®, SPINRAZA, Litifilimab, Lecanemab, salanersen, nusinersen, and BIIB059. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
LEQEMBI® (lecanemab-irmb) FDA Regulatory Timeline and Events
LEQEMBI® (lecanemab-irmb) is a drug developed by Biogen for the following indication: Treatment of Alzheimer's Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- May 8, 2026
- Indication:
- Treatment of Alzheimer's Disease
Announcement
Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the review period by three months for the supplemental Biologics License Application (sBLA) for a once-weekly lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI® IQLIK™) as a starting dose for the treatment of early Alzheimer's disease.
AI Summary
Eisai Co., Ltd. and Biogen Inc. announced the U.S. Food and Drug Administration has extended the review by three months for the supplemental Biologics License Application (sBLA) seeking approval of a once‑weekly subcutaneous lecanemab‑irmb injection, LEQEMBI IQLIK, as a starting dose for early Alzheimer’s disease. The agency requested additional information that it deemed a major amendment to the sBLA, so the PDUFA target date was moved to allow time for a full review. The FDA has not raised any approvability concerns to date.
The companies say a comprehensive clinical data package evaluating subcutaneous administration across multiple studies and dosing regimens supports the potential use of LEQEMBI IQLIK for initiation therapy. They noted LEQEMBI has been approved by more than 50 regulatory authorities worldwide and said they look forward to ongoing discussions with the FDA as the review progresses to bring more treatment flexibility to patients and caregivers.
Read Announcement- Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- January 25, 2026
- Indication:
- Treatment of Alzheimer's Disease
Announcement
Eisai Co. and Biogen Inc announced that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai's Supplemental Biologics License Application (sBLA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector (SC-AI), LEQEMBI IQLIK, as a weekly starting dose..
AI Summary
Eisai and Biogen said the U.S. Food and Drug Administration has accepted for review a supplemental biologics license application for LEQEMBI IQLIK, a subcutaneous autoinjector formulation of lecanemab, with a Priority Review and a PDUFA action date of May 24, 2026. If approved, LEQEMBI IQLIK would be the first and only anti-amyloid treatment to offer at-home injection options for both treatment initiation and ongoing dosing for early Alzheimer’s disease.
The proposed starting regimen is 500 mg delivered as two 250 mg autoinjector injections once weekly, as an alternative to the current bi-weekly intravenous dosing. Each 250 mg injection takes about 15 seconds. Subcutaneous use could let patients and caregivers choose home administration and may reduce the healthcare resources tied to IV infusions, such as infusion setup and nurse monitoring.
Supportive data from Clarity AD open-label substudies show once-weekly 500 mg subcutaneous dosing achieved equivalent exposure to every-two-week IV dosing, with similar clinical and biomarker effects. The safety profile was comparable to IV administration, with systemic injection or infusion-related reactions reported in under 2% of cases.
Read Announcement- Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- January 5, 2026
- Indication:
- Treatment of Alzheimer's Disease
Announcement
Eisai Co. and Biogen Inc. announced that the Biologics License Application (BLA) for the subcutaneous formulation (subcutaneous autoinjector: SC-AI) of "LEQEMBI®" (brand name in China: "乐意保®", generic name: lecanemab), an anti-amyloid beta (Aβ) protofibril antibody, has been accepted by the National Medical Products Administration (NMPA) in China.
AI Summary
Eisai Co. and Biogen Inc. announced that China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for the subcutaneous autoinjector (SC-AI) formulation of LEQEMBI® (乐意保®, generic name lecanemab), an anti-amyloid beta protofibril antibody. If approved, the SC-AI 500 mg dose (two 250 mg injections) could allow once-weekly at-home treatment from the start of therapy instead of hospital intravenous infusions. Each 250 mg autoinjector delivers its injection in about 15 seconds.
The subcutaneous option could reduce healthcare resources tied to IV dosing—such as infusion preparation and nurse monitoring—and simplify the Alzheimer’s care pathway. Eisai estimates roughly 17 million people in China had mild cognitive impairment or mild dementia due to Alzheimer’s in 2024, a figure expected to rise. Eisai leads global development and regulatory filings, will distribute the product in China, and will provide information through specialized medical representatives, with Eisai and Biogen co-promoting the treatment.
Read Announcement- Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- December 3, 2025
- Indication:
- Treatment of Alzheimer's Disease
Announcement
Eisai Co., and Biogen Inc. announced that the latest findings on time savings with continued treatment with humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody lecanemab (generic name, U.S. brand name LEQEMBI®) were presented at the 18th Clinical Trials on Alzheimer's Disease (CTAD) Conference.
AI Summary
Eisai and Biogen reported new findings at the 18th CTAD Conference showing that continued treatment with lecanemab (LEQEMBI®) may significantly delay Alzheimer’s progression. Using long-term clinical data, researchers estimated that lecanemab extended time from mild cognitive impairment (MCI) to mild Alzheimer’s by about 2.5 years versus no treatment. In patients who began treatment early with low brain amyloid, the delay to mild Alzheimer’s was about 6.0 years.
For progression from MCI to moderate Alzheimer’s, lecanemab showed an estimated delay of about 3.5 years versus untreated patients. In the low-amyloid, early-treatment group, the delay was estimated at 8.3 years. The analysis suggested earlier start and continued use offer greater benefit, and each additional year on treatment may further slow decline.
A symposium also presented data on a subcutaneous lecanemab formulation that achieved similar drug exposure to IV dosing (exposure ratio ~104%) and comparable predicted safety and efficacy, with fewer systemic infusion reactions observed in the SC groups.Read Announcement
- Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- December 2, 2025
- Indication:
- Treatment of Alzheimer's Disease
Announcement
Eisai Co., Ltd. and Biogen Inc announced today that the latest data confirming the pharmacological effect of lecanemab (generic name, U.S. brand name: LEQEMBI®), an anti-Aβ protofibril* antibody, on Aβ protofibrils (PF) in cerebrospinal fluid (CSF) was presented at the 18th Clinical Trials on Alzheimer's Disease (CTAD) Conference.
AI Summary
Eisai and Biogen presented new CTAD data showing lecanemab’s pharmacological effect on amyloid‑β protofibrils (PF) in cerebrospinal fluid (CSF) from a Phase III Clarity AD CSF sub‑cohort (n=410). Using an ultrasensitive assay, total CSF PF rose in placebo by 19% at 12 months and 29% at 18 months, while the lecanemab group rose 59% at 12 months and 45% at 18 months. The 12‑month difference versus placebo was statistically significant (p=0.0126).
The researchers interpret the larger CSF PF increase with treatment as evidence that lecanemab binds PF and mobilizes them from brain tissue into CSF (target engagement and pharmacodynamic effect). In placebo patients, PF changes correlated with neurodegeneration and tau biomarkers (total tau, neurogranin, p‑tau181, MTBR‑tau243); these correlations disappeared with lecanemab, suggesting reduced PF‑linked neurotoxicity and a mechanism that may slow downstream tau pathology.
Read Announcement- Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- November 27, 2025
- Indication:
- Treatment of Alzheimer's Disease
Announcement
Eisai Co., and Biogen Inc. announced that Eisai has filed a new drug application for "LEQEMBI®" (brand name, generic name: lecanemab) seeking approval for a subcutaneous formulation (subcutaneous autoinjector: SC-AI) as a new route of administration to Japan's Pharmaceuticals and Medical Devices Agency (PMDA).
AI Summary
Eisai Co. and Biogen announced that Eisai has filed a new drug application with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) seeking approval of a subcutaneous autoinjector (SC‑AI) formulation of LEQEMBI (lecanemab). The filing is based on sub-studies from the Phase 3 Clarity AD open‑label extension showing that once‑weekly SC‑AI 500 mg (two 250 mg injections) produced drug exposure equivalent to intravenous dosing every two weeks, with similar clinical and biomarker effects. Safety with subcutaneous dosing was comparable to IV administration, and systemic injection/infusion‑related reactions occurred in under 2% of patients.
If approved, the SC‑AI could allow patients to start once‑weekly at‑home treatment instead of biweekly IV infusions in hospital. Each 250 mg autoinjector delivers an injection in about 15 seconds. Eisai leads global development of lecanemab and co‑commercializes the medicine with Biogen, and the SC option could reduce infusion preparation and nurse monitoring, simplifying Alzheimer’s care.
Read Announcement- Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- November 25, 2025
- Indication:
- Treatment of Alzheimer's Disease
Announcement
Eisai Co., and Biogen Inc. announced today that Eisai has completed the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb
AI Summary
Eisai Co., Ltd. and Biogen Inc. announced that Eisai has completed the rolling submission of a supplemental Biologics License Application (sBLA) to the U.S. FDA for lecanemab-irmb (LEQEMBI) subcutaneous autoinjector, LEQEMBI IQLIK, as a weekly starting dose after the FDA granted Fast Track status. If the FDA accepts the sBLA, it will set a Prescription Drug User Fee Act (PDUFA) action date for review.
The submission is supported by data from sub-studies in the Phase 3 Clarity AD open‑label extension. Results show once‑weekly 500 mg subcutaneous autoinjector dosing achieved equivalent drug exposure to every‑two‑weeks intravenous dosing and produced similar clinical and biomarker effects. The safety profile was comparable, with systemic injection or infusion reactions reported in under 2% of patients.
If approved, the 500 mg regimen (two 250 mg injections) could offer a once‑weekly starting alternative to bi‑weekly IV infusions, enable at‑home administration, shorten injection time to about 15 seconds, and reduce infusion‑related healthcare resources. Eisai leads global development and regulatory submissions, with Eisai and Biogen co‑commercializing the product.
Read Announcement- Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- November 20, 2025
- Indication:
- Treatment of Alzheimer's Disease
Announcement
Biogen Inc. announced upcoming scientific presentations at the 18th Clinical Trials on Alzheimer's Disease (CTAD) Conference, taking place December 1-4 in San Diego. Data on LEQEMBI® (lecanemab-irmb) will include findings on subcutaneous administration for initiation dosing, the benefits of continued therapy and estimated time savings over 10 years of treatment based on Phase 3 clinical data, and real-world experience from a post-marketing observational study in Japan and the ALZ-NET registry.
AI Summary
Biogen announced it will present new scientific findings on LEQEMBI® (lecanemab-irmb) at the 18th Clinical Trials on Alzheimer’s Disease (CTAD) conference, Dec. 1–4 in San Diego. The company plans multiple oral and poster sessions to explain the data to clinicians and researchers.
Key results include data on subcutaneous administration for initiation dosing, suggesting this route may be safe and could simplify the start of treatment. Analyses from Phase 3 studies (including CLARITY AD and TRAILBLAZER‑ALZ2) examine how benefit accumulates with continued therapy, including benefits after plaque clearance, and offer estimates of time saved over a 10‑year treatment horizon.
Biogen will also report real‑world experience from a post‑marketing observational study in Japan and from the U.S. ALZ‑NET registry, covering safety, patient outcomes, and signals of stability or improvement in early Alzheimer’s disease as treatment is used outside clinical trials.
Read Announcement- Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- November 13, 2025
- Indication:
- Treatment of Alzheimer's Disease
Announcement
Eisai Co and Biogen Inc announced that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMBI®" (generic name: lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom..
AI Summary
Eisai and Biogen announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom approved LEQEMBI (generic name: lecanemab) for intravenous maintenance dosing once every four weeks. After an initial 18‑month treatment of 10 mg/kg every two weeks, patients may be transitioned to 10 mg/kg every four weeks or may continue the every‑two‑week regimen.
LEQEMBI was previously approved in the UK for adults with mild cognitive impairment and mild dementia due to Alzheimer’s disease who are ApoE ε4 heterozygotes or non‑carriers. Lecanemab is a humanized monoclonal antibody that targets soluble aggregated amyloid‑beta protofibrils and insoluble plaques and can affect tau pathology downstream.
The companies note that Alzheimer’s biomarkers can reaccumulate and clinical decline may return if treatment stops, so ongoing maintenance dosing is important to help slow disease progression and extend benefits. Eisai leads development and co‑markets the drug with Biogen. In the UK, an estimated 982,000 people live with dementia, with Alzheimer’s causing 60–70% of cases.
Read Announcement- Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- October 27, 2025
- Indication:
- Treatment of Alzheimer's Disease
Announcement
Eisai Co., announced today that Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMBI®" (lecanemab) for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment or mild dementia due to Alzheimer's disease (early AD) who are apolipoprotein E ε4 (ApoE ε4*) non-carriers or heterozygotes and who have confirmed amyloid pathology.
AI Summary
Eisai announced that Health Canada granted a Notice of Compliance with Conditions for LEQEMBI® (lecanemab) for patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease who are apolipoprotein E ε4 non-carriers or heterozygotes and have confirmed amyloid pathology. LEQEMBI is the first disease-modifying therapy for early AD approved in Canada.
Lecanemab binds selectively to soluble amyloid-β aggregates (protofibrils) and insoluble fibrils, reducing both protofibrils and plaque in the brain. In the global Phase 3 Clarity AD study, LEQEMBI significantly slowed disease progression and reduced cognitive and functional decline in patients with early AD. Approval is conditional pending ongoing confirmatory trials.
Eisai leads global development of lecanemab and works with Biogen to co-commercialize it. In Canada, Eisai Limited will distribute LEQEMBI. Alzheimer’s disease affects over 770,000 Canadians and is projected to rise. Eisai and Biogen will work with healthcare professionals on early treatment access.
Read Announcement- Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- October 6, 2025
- Indication:
- Treatment of Alzheimer's Disease
Announcement
Eisai Co., Ltd. and Biogen Inc. announced that lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI® IQLIKTM) is now available in the U.S. as a maintenance dosing regimen for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD).
AI Summary
Eisai Co., Ltd. and Biogen Inc. announced that their lecanemab-irmb subcutaneous injection, branded as LEQEMBI® IQLIK™, is now available in the U.S. as a maintenance dosing option for early Alzheimer’s patients. This treatment is intended for those with mild cognitive impairment or mild dementia stage of disease.
After completing 18 months of intravenous infusions at 10 mg/kg every two weeks, patients can switch to a weekly 360 mg subcutaneous injection using the LEQEMBI IQLIK autoinjector. This at-home option aims to reduce time spent at infusion centers and ease the treatment process for patients and caregivers.
Alongside the new dosing regimen, Eisai and Biogen launched the LEQEMBI Companion™ program. This support initiative offers resources like nurse-led injection training, a digital app for tracking injections, educational welcome kits, and help with insurance coverage and financial support programs to guide patients throughout their treatment journey.
Read Announcement- Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- September 28, 2025
- Indication:
- Treatment of Alzheimer's Disease
Announcement
Eisai Co., and Biogen Inc. announced that humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMBI®" (brand name in China: "乐意保®", generic name: lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing by the National Medical Products Administration (NMPA) in China.
AI Summary
Eisai Co., Ltd. and Biogen Inc. announced approval of LEQEMBI (generic name lecanemab, brand name 乐意保) for once-every-four-week intravenous maintenance dosing by China’s National Medical Products Administration (NMPA). LEQEMBI was first approved in January 2024 to treat early Alzheimer’s disease in patients with mild cognitive impairment or mild dementia. After an 18-month initiation phase of 10 mg/kg every two weeks, patients can switch to a 10 mg/kg dose every four weeks or continue the two-week schedule.
Alzheimer’s disease causes amyloid-beta plaques and tau tangles to build up in the brain, leading to ongoing nerve cell damage. LEQEMBI is the only approved therapy that fights disease both by clearing plaques and by targeting toxic soluble protofibrils that drive tau-related injury.
In China, about 17 million people live with mild cognitive impairment or mild dementia due to Alzheimer’s, and that number is growing. Eisai leads global development of lecanemab and, together with Biogen, co-promotes the treatment in China.
Read Announcement- Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- September 1, 2025
- Indication:
- Treatment of Alzheimer's Disease
Announcement
Eisai Co., Ltd. and Biogen Inc announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab-irmb subcutaneous injection (U.S. brand name: LEQEMBI® IQLIKTM, pronounced "I Click") for maintenance dosing. LEQEMBI IQLIK is a subcutaneous autoinjector (SC-AI) developed by Eisai, containing 360 mg/1.8 mL (200 mg/mL) that can be administered in approximately 15 seconds.
AI Summary
Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration has approved the Biologics License Application for once-weekly lecanemab-irmb subcutaneous injection, branded as LEQEMBI IQLIK. This 360 mg/1.8 mL autoinjector delivers a maintenance dose in about 15 seconds for patients with early Alzheimer’s disease following 18 months of intravenous treatment.
The approval is based on Phase 3 Clarity AD open-label extension substudies showing that switching to the weekly subcutaneous dose maintains clinical and biomarker benefits similar to continued IV infusions. In over 600 patients, systemic reactions were under 1% compared to 26% with IV dosing. About 11% experienced mild local injection-site reactions, and ARIA rates remained comparable to IV treatment and background levels in untreated patients.
The LEQEMBI IQLIK autoinjector offers home administration, shorter dosing time, and reduced infusion-center resources. Eisai will provide patient navigators, injection support, and a Patient Assistance Program. LEQEMBI IQLIK will launch in the U.S. on October 6, 2025.
Read Announcement- Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- July 30, 2025
- Indication:
- Treatment of Alzheimer's Disease
Announcement
Eisai Co., Ltd. and Biogen Inc announced that results on investigational maintenance therapy with subcutaneous autoinjector (SC-AI) of lecanemab-irmb (U.S. brand name: LEQEMBI®), an anti-amyloid beta (Aβ) protofibril* antibody for the treatment of early Alzheimer's disease (AD), were presented at the Alzheimer's Association International Conference (AAIC) 2025, held in Toronto, and virtually. Only lecanemab fights AD in two ways— targeting both protofibrils and plaque, which can impact tau accumulation downstream.
AI Summary
Eisai Co., Ltd. and Biogen Inc. announced at the Alzheimer’s Association International Conference (AAIC) 2025 new data on the subcutaneous autoinjector (SC-AI) of lecanemab-irmb (LEQEMBI®) for early Alzheimer’s disease. Lecanemab uniquely targets both amyloid-β protofibrils and plaques, addressing multiple steps in disease progression and downstream tau accumulation.
In an open-label extension study after an 18-month intravenous (IV) initiation, weekly 360 mg SC-AI dosing maintained clinical and biomarker benefits similar to biweekly IV dosing. Safety was consistent, with under 1% systemic reactions and no ARIA-E cases in patients treated for six months. A human factors study showed 95% of patients, care partners, and healthcare professionals successfully administered the SC-AI, and over 95% found it easy to use. The SC formulation could offer patients at-home treatment, shorter administration times, and ongoing access without frequent infusion center visits.
Read Announcement- Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- February 28, 2025
- Indication:
- Treatment of Alzheimer's Disease
Announcement
BioArctic AB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reaffirmed its positive opinion for the anti-Aβ monoclonal antibody lecanemab (Leqembi®), adopted in November 2024.
AI Summary
BioArctic AB, in partnership with Eisai, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reaffirmed its positive opinion for the anti-Aβ monoclonal antibody lecanemab (Leqembi®), originally adopted in November 2024. The CHMP reviewed additional safety data requested by the European Commission and concluded that the initial positive opinion remains unchanged. Following this reaffirmation, the European Commission will now resume its decision-making process to grant marketing authorization for lecanemab across the European Union and associated countries, including Iceland, Liechtenstein, and Norway.
Lecanemab is designed to target and reduce harmful amyloid-beta aggregates that contribute to early Alzheimer’s disease. This continued regulatory support is an important step toward making lecanemab available to patients in need.
Read Announcement- Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- January 26, 2025
- Indication:
- Treatment of Alzheimer's Disease
Announcement
Eisai Co., Ltd. and Biogen Inc announced that the U.S. Food and Drug Administration (FDA) has approved the Supplemental Biologics License Application (sBLA) for once every four weeks lecanemab-irmb (U.S. brand name: LEQEMBI®) intravenous (IV) maintenance dosing. LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD) in the U.S.
AI Summary
Eisai Co., Ltd. and Biogen Inc. announced that the U.S. FDA approved a Supplemental Biologics License Application (sBLA) for LEQEMBI® (lecanemab-irmb) using a once‐every‐four-weeks intravenous maintenance dosing regimen. This approval targets patients with early Alzheimer’s disease, including those with mild cognitive impairment or mild dementia. The new dosing schedule comes after an 18-month phase where patients initially receive treatment every two weeks, with a transition option to a 10 mg/kg dosing every four weeks. Modeling data from Phase 2 and Phase 3 studies suggest that switching to the four-week maintenance dose will continue to deliver clinical benefits and help slow the progression of Alzheimer’s disease. This updated dosing regimen may offer an easier treatment schedule for patients and their caregivers.
Read Announcement - Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- January 13, 2025
- Indication:
- Treatment of Alzheimer's Disease
Announcement
Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted Eisai's Biologics License Application (BLA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector (SC-AI) for weekly maintenance dosing.
AI Summary
Eisai Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Biologics License Application (BLA) for its lecanemab-irmb subcutaneous autoinjector (SC-AI), marketed as LEQEMBI®. This new formulation is designed for weekly maintenance dosing in patients with early Alzheimer’s disease, specifically those with mild cognitive impairment or mild dementia. The acceptance is based on data from the Clarity AD open-label extension study and modeling analyses. If approved, LEQEMBI’s subcutaneous option would be the only Alzheimer’s treatment that patients could self-administer at home using an autoinjector, potentially reducing the need for frequent hospital visits. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date for August 31, 2025, which signals when a decision on this innovative treatment method might be expected.
Read Announcement- Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- August 22, 2024
- Indication:
- Treatment of Alzheimer's Disease
Announcement
Eisai Co., Ltd. and Biogen Inc. announced that the humanized amyloid-beta (Aβ) monoclonal antibody "Leqembi®" (brand name, generic name: lecanemab) has been granted a Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain.
AI Summary
Eisai Co., Ltd. and Biogen Inc. announced that their humanized amyloid-beta monoclonal antibody, Leqembi® (lecanemab), has received Marketing Authorization from Great Britain’s Medicines and Healthcare products Regulatory Agency (MHRA). This approval marks the first authorization in Europe for a treatment that targets an underlying cause of Alzheimer’s disease. Leqembi is indicated for adult patients with mild cognitive impairment and mild dementia due to Alzheimer’s, specifically for those who are apolipoprotein E ε4 heterozygotes or non-carriers.
The decision was based on strong Phase 3 clinical trial results that demonstrated the treatment’s ability to slow cognitive decline. Eisai and Biogen are working together to ensure that eligible patients gain timely access to this innovative therapy, representing a significant advancement in the management of early Alzheimer’s disease in Europe.
Read Announcement- Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- July 30, 2024
- Indication:
- Treatment of Alzheimer's Disease
Announcement
Eisai Co., Ltd. announced today that the latest findings for lecanemab-irmb (U.S. brand name: LEQEMBI®), an anti-amyloid beta (Aβ) protofibril* antibody for the treatment of early Alzheimer's disease (AD), were presented at the Alzheimer's Association International Conference (AAIC) 2024, held in Philadelphia, USA, and virtually. and Biogen Inc
AI Summary
Eisai Co., Ltd. and Biogen Inc. announced new findings at the Alzheimer’s Association International Conference (AAIC) 2024, held both in Philadelphia and online. The data focused on lecanemab‐irmb (U.S. brand name: LEQEMBI®), an anti-amyloid beta (Aβ) protofibril antibody developed for treating early Alzheimer’s disease. Lecanemab-irmb is designed to clear highly toxic protofibrils—damaging particles that continue to hurt brain cells even after the removal of amyloid plaques—thereby supporting neuronal function and slowing the spread of tau, a protein linked to disease progression.
Eisai leads the global development and regulatory submissions for lecanemab-irmb, while Biogen collaborates in its co-commercialization and promotion. The presentation at AAIC 2024 highlighted the potential of early intervention with this dual-acting treatment to improve outcomes for patients with early Alzheimer’s disease.
Read Announcement- Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- June 9, 2024
- Indication:
- Treatment of Alzheimer's Disease
Announcement
Biogen Inc and Eisai Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted Eisai's Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: LEQEMBI®) intravenous (IV) maintenance dosing.
AI Summary
Biogen Inc. and Eisai Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: LEQEMBI®) intravenous maintenance dosing. Under this proposed regimen, patients who complete the initial biweekly dosing phase would switch to a monthly infusion, which helps maintain effective drug levels to clear toxic protofibrils implicated in Alzheimer’s disease.
The acceptance is based on modeling from Phase 2 and Phase 3 studies, supporting the sustained therapeutic benefits of LEQEMBI in early Alzheimer’s patients. A Prescription Drug User Fee Act action date is set for January 25, 2025. This development demonstrates continued collaboration between Eisai and Biogen to enhance treatment options for Alzheimer’s disease.
Read Announcement- Drug:
- LEQEMBI® (lecanemab-irmb)
- Announced Date:
- May 14, 2024
- Indication:
- Treatment of Alzheimer's Disease
Announcement
Eisai Co., Ltd and Biogen Inc. announced that that Eisai has initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA.
AI Summary
Eisai Co., Ltd. and Biogen Inc. have announced an important advancement in their efforts to bring innovative treatments to patients. Eisai has started the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its lecanemab-irmb subcutaneous autoinjector. This device, known in the U.S. as LEQEMBI®, is designed for weekly maintenance dosing.
The submission follows the FDA’s Fast Track designation, a status that can speed up the review process for promising therapies. By using a rolling submission process, the FDA can evaluate sections of the application as they become available, which may help bring the treatment to market more quickly. This step reflects the companies’ commitment to accelerating access to this potentially beneficial therapy.
Read Announcement
SPINRAZA (Nusinersen) FDA Regulatory Timeline and Events
SPINRAZA (Nusinersen) is a drug developed by Biogen for the following indication: Spinal muscular atrophy (SMA).
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SPINRAZA (Nusinersen)
- Announced Date:
- March 30, 2026
- Indication:
- Spinal muscular atrophy (SMA)
Announcement
Biogen Inc announced that the High Dose Regimen of SPINRAZA® (nusinersen), which is comprised of 50 mg/5 mL and 28 mg/5 mL doses, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of spinal muscular atrophy (SMA). Backed by more than 10 years of clinical data supporting the Low Dose Regimen of SPINRAZA (12 mg), High Dose SPINRAZA was designed to deliver a higher concentration of drug through both the loading and maintenance dosing phases, to provide a new option in response to the ongoing needs of the community.
AI Summary
Biogen Inc announced the FDA approval of the High Dose Regimen of SPINRAZA® (nusinersen), comprised of 50 mg/5 mL and 28 mg/5 mL doses, for the treatment of spinal muscular atrophy (SMA). Backed by more than 10 years of clinical data supporting the Low Dose Regimen of SPINRAZA (12 mg), High Dose SPINRAZA was designed to deliver a higher concentration of drug through both the loading and maintenance dosing phases to provide a new option for the SMA community.
The approval was anchored on data from the pivotal DEVOTE study in treatment‑naïve and previously treated patients. The High Dose regimen showed meaningful clinical benefit while maintaining a well‑characterized safety profile. It is also approved in the European Union, Switzerland and Japan.
The dosing enables an accelerated loading phase for new patients—two 50 mg doses 14 days apart—followed by 28 mg maintenance injections every four months. Patients switching from the 12 mg schedule will follow their four‑month maintenance timing after a single High Dose loading phase. High Dose SPINRAZA will be available in the United States in the coming weeks.
Read Announcement- Drug:
- SPINRAZA (Nusinersen)
- Announced Date:
- January 12, 2026
- Indication:
- Spinal muscular atrophy (SMA)
Announcement
Biogen Inc. announced the European Commission (EC) has granted marketing authorization for a high dose regimen of SPINRAZA® (nusinersen) which is comprised of 50 mg/5 mL and 28 mg/5 mL doses for the treatment of 5q spinal muscular atrophy (SMA).
AI Summary
Biogen announced the European Commission has approved a high dose regimen of SPINRAZA® (nusinersen) for 5q spinal muscular atrophy (SMA). The updated EU marketing authorization covers 50 mg/5 mL and 28 mg/5 mL doses, given as two 50 mg loading injections 14 days apart, followed by 28 mg maintenance injections every four months. People switching from the prior 12 mg dose will receive one 50 mg dose in place of their next 12 mg dose, then continue with 28 mg maintenance. SPINRAZA is given intrathecally by lumbar puncture performed by trained health care professionals.
The approval is supported by the Phase 2/3 DEVOTE study. Treatment‑naïve infants on the high dose showed significant motor gains on CHOP‑INTEND versus a matched untreated group (mean difference 26.19 points; +15.1 vs. -11.1, p<0.0001). Participants who transitioned from 12 mg also improved on the Hammersmith Functional Motor Scale–Expanded (mean +1.8 points at Day 302). The high dose was generally well tolerated, with adverse events consistent with SMA and the known nusinersen profile; precautions include risks from lumbar puncture, low platelets, renal toxicity and hydrocephalus.
Read Announcement- Drug:
- SPINRAZA (Nusinersen)
- Announced Date:
- June 25, 2025
- Indication:
- Spinal muscular atrophy (SMA)
Announcement
Ionis Pharmaceuticals, Inc. announced that its partner, Biogen, shared positive topline results from the Phase 1 study of salanersen (ION306/BIIB115), an investigational antisense oligonucleotide (ASO) being developed for the potential treatment of spinal muscular atrophy (SMA).
AI Summary
Ionis Pharmaceuticals announced positive topline results from the Phase 1 study of salanersen (ION306/BIIB115), an investigational antisense oligonucleotide being developed with partner Biogen for treating spinal muscular atrophy (SMA). The study showed that children with SMA who had previously received gene therapy experienced a substantial slowing of neurodegeneration and significant improvements in motor function. Both tested doses – 40 mg and 80 mg, given once-yearly – were generally well-tolerated, and reductions in neurofilament levels indicated slowed disease progression. Biogen plans to engage with regulators to move salanersen into registrational stage studies. Ionis highlighted that salanersen was created using their novel antisense chemistry, which may offer higher potency and the benefit of long-interval dosing, potentially offering improved treatment options for the SMA community.
Read Announcement- Drug:
- SPINRAZA (Nusinersen)
- Announced Date:
- July 31, 2024
- Indication:
- Spinal muscular atrophy (SMA)
Announcement
Alcyone Therapeutics Inc. announced today that the U.S. Food and Drug Administration (FDA) has provided approval to continue enrollment of the PIERRE study (https://clinicaltrials.gov/ct2/show/NCT05866419) to evaluate the safety and effectiveness of the ThecaFlex DRx™ subcutaneous port and intrathecal catheter system for chronic intrathecal access, CSF aspiration, and delivery of SPINRAZA® (nusinersen) in SMA patients as an alternative to repeat lumbar puncture (LP).
AI Summary
Alcyone Therapeutics Inc. announced that the FDA has approved the continuation of enrollment for the PIERRE study, which is designed to evaluate the safety and effectiveness of the ThecaFlex DRx™ subcutaneous port and intrathecal catheter system. This innovative device aims to provide chronic intrathecal access for cerebrospinal fluid (CSF) aspiration and the delivery of SPINRAZA® (nusinersen) in patients with spinal muscular atrophy (SMA), offering an alternative to the traditional repeat lumbar puncture. In the first stage of the trial, 10 SMA patients successfully underwent ThecaFlex implantation with no device-related adverse events observed within 30 days. Based on the positive initial clinical data, the FDA has allowed an additional 80 patients to be enrolled across up to 30 centers in the United States and Europe, marking an important step toward a less invasive treatment method for SMA patients.
Read Announcement
Litifilimab FDA Regulatory Events
Litifilimab is a drug developed by Biogen for the following indication: Litifilimab is a potential first in-class, monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Litifilimab
- Announced Date:
- March 28, 2026
- Indication:
- Litifilimab is a potential first in-class, monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2)
Announcement
Biogen Inc. announced positive results from the Phase 2 part of the AMETHYST Phase 2/3 study (Part A) of litifilimab in people living with cutaneous lupus erythematosus (CLE). Litifilimab is the first humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2), which has the potential to become the first innovative therapy approved for CLE in 70 years.
AI Summary
Biogen Inc. announced positive results from the Phase 2 portion (Part A) of the AMETHYST Phase 2/3 study of litifilimab in people living with cutaneous lupus erythematosus (CLE). The company reported encouraging outcomes that support continued development of the drug in later-stage trials. These findings highlight potential clinical activity in CLE and provide a rationale for advancing litifilimab toward confirmatory testing.
Litifilimab is the first humanized IgG1 monoclonal antibody designed to target blood dendritic cell antigen 2 (BDCA2). If approved, it could become the first innovative targeted therapy for CLE in about 70 years. CLE is a complex, heterogeneous disease that affects millions worldwide, and today there are no approved targeted treatments. Litifilimab remains investigational and is not approved by any regulatory authority; its safety and effectiveness have not been established.
Read Announcement- Drug:
- Litifilimab
- Announced Date:
- March 19, 2026
- Indication:
- Litifilimab is a potential first in-class, monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2)
Announcement
Biogen announced upcoming scientific presentations at the 2026 American Academy of Dermatology (AAD) Annual Meeting, taking place March 27-31. Late-breaking data from Part A (Phase 2) of the AMETHYST Phase 2/3 study will be presented that highlight litifilimab's effect on cutaneous lupus erythematosus (CLE) disease activity.
AI Summary
Biogen said it will present new scientific data at the 2026 American Academy of Dermatology (AAD) Annual Meeting, March 27–31, highlighting litifilimab’s effects on cutaneous lupus erythematosus (CLE). Late-breaking results from Part A (Phase 2) of the AMETHYST Phase 2/3 study will be shared, focusing on changes in CLE disease activity with litifilimab treatment. The announcement frames these findings as important new data for clinicians and researchers following CLE treatment development.
Presentation details: a Late-Breaking Oral Presentation titled “Efficacy and Safety of Litifilimab in Cutaneous Lupus Erythematosus (CLE): 24‑week results of the Phase 2 Study, AMETHYST Part A” will be presented Saturday, March 28 at 3:24 PM MT / 5:24 PM ET in Bellco Theatre 3 (abstract #79781). Two key posters will be on display in the Poster Exhibits Center: “A Qualitative Study to Support the Content Validity of the Cutaneous Lupus Activity Investigator’s Global Assessment—Revised (CLA‑IGA‑R): Clinician Perspectives” (#71096) and “Correlation Between CLASI and CLA‑IGA‑R Among Patients With CLE in a Multi‑Center Cross‑Sectional Study in the US” (#75155). Litifilimab is investigational and not approved; its safety and effectiveness have not been established.
Read Announcement
Lecanemab (BAN2401) FDA Regulatory Timeline and Events
Lecanemab (BAN2401) is a drug developed by Biogen for the following indication: Anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease (AD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Lecanemab (BAN2401)
- Announced Date:
- March 23, 2026
- Indication:
- Anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease (AD)
Announcement
BioArctic's AB partner Eisai presented new data at the 2026 International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders (AD/PD™), held in Copenhagen, Denmark March 17-21.
AI Summary
Eisai, BioArctic’s development partner for lecanemab, presented new data at the 2026 AD/PD conference in Copenhagen (March 17–21). The company shared findings focused on real-world use of lecanemab, aiming to show how patients stay on treatment over time outside of clinical trials.
The presentation used the PurpleLab® CLEAR Claims database, which draws on U.S. medical insurance claims, to evaluate long-term treatment persistence and adherence to lecanemab in routine clinical practice. The data highlighted persistence and adherence as important factors that can affect treatment outcomes and health-care quality.
BioArctic originally developed the antibody based on Professor Lannfelt’s discovery of the Arctic mutation. The materials stressed that these are investigational findings and do not prove efficacy or safety; there is no guarantee the agent will complete development or gain approval.
Read Announcement- Drug:
- Lecanemab (BAN2401)
- Announced Date:
- February 8, 2026
- Indication:
- Anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease (AD)
Announcement
Eisai Co., and Biogen Inc announced today that the Biologics License Application (BLA) for the subcutaneous formulation (subcutaneous autoinjector: SC-AI) of "LEQEMBI®" (brand name in China: "乐意保®", generic name: lecanemab), an anti-amyloid beta (Aβ) protofibril antibody, which was accepted in January 2026, has been designated for Priority Review by the National Medical Products Administration (NMPA) of China..
AI Summary
Eisai Co. and Biogen Inc. announced that the Biologics License Application (BLA) for the subcutaneous autoinjector (SC‑AI) formulation of LEQEMBI® (Chinese brand: 乐意保®, generic: lecanemab), an anti‑amyloid beta (Aβ) protofibril antibody, was accepted in January 2026 and has been designated for Priority Review by China’s National Medical Products Administration (NMPA). The NMPA’s Priority Review and Approval Procedure is intended to speed the research, development and launch of medicines with significant clinical value by shortening the assessment period.
Eisai estimates about 17 million people in China had mild cognitive impairment or mild dementia due to Alzheimer’s disease in 2024, a figure expected to rise as the population ages. Eisai leads global development and regulatory filings for lecanemab; Eisai and Biogen will co‑commercialize and co‑promote the product, with Eisai holding final decision authority. In China, Eisai will handle distribution and provide information through specialized Medical Representatives.
Read Announcement- Drug:
- Lecanemab (BAN2401)
- Announced Date:
- December 8, 2025
- Indication:
- Anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease (AD)
Announcement
Eisai Co., and Biogen Inc. announced today that anti-Aβ protofibril* antibody "LEQEMBI®" (brand name in China: "乐意保®", generic name: lecanemab), has been included in the "Commercial Insurance Innovative Drug List" (Chinese: 商业健康保险创新药品目录), recently introduced by the National Healthcare Security Administration (NHSA) of China.
AI Summary
Eisai Co. and Biogen announced that LEQEMBI® (Chinese brand: 乐意保®, generic: lecanemab), an anti-Aβ protofibril antibody for early Alzheimer’s disease, has been added to China’s new "Commercial Insurance Innovative Drug List" (商业健康保险创新药品目录) issued by the National Healthcare Security Administration (NHSA). The list takes effect January 1, 2026.
The Commercial Insurance Innovative Drug List is designed to narrow the coverage gap between the standard National Reimbursement Drug List (NRDL) and innovative medicines. Under the policy, commercial insurers will negotiate coverage details with drugmakers and create insurance products that include listed medicines, improving access beyond basic reimbursement schemes.
Eisai launched LEQEMBI in China in June 2024 and has supplied it in the private market. Protofibrils are believed to be a highly toxic form of amyloid‑beta that contributes to neuron damage and cognitive decline in Alzheimer’s disease; targeting them may slow disease progression. Eisai leads global development and, together with Biogen, co‑commercializes the product in China, where Eisai will distribute and provide information via specialized medical representatives.
Read Announcement- Drug:
- Lecanemab (BAN2401)
- Announced Date:
- September 24, 2025
- Indication:
- Anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease (AD)
Announcement
Eisai Co. and Biogen Inc. announced that the Therapeutic Goods Administration (TGA) of Australia has approved the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMBI®" (brand name, generic name: lecanemab) for mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (AD) (collectively referred to as early AD) in adults who are either ApoEε4* non-carriers or heterozygous carriers.
AI Summary
Eisai and Biogen announced that Australia’s Therapeutic Goods Administration has approved LEQEMBI® (lecanemab) for mild cognitive impairment or mild dementia due to Alzheimer’s disease in adults with no copies or one copy of the ApoEε4 gene.
It follows a February 2025 decision not to approve the treatment and a review request by Eisai. Through discussions at the Administrative Review Tribunal in March 2025, the TGA and Eisai reached an agreement leading to approval.
About 425,000 Australians lived with dementia in 2024, a figure expected to rise to nearly 1.1 million by 2065. Alzheimer’s disease causes 60–70% of dementia cases and involves progressive brain damage from amyloid beta and tau proteins.
LEQEMBI works by targeting both soluble amyloid protofibrils and insoluble plaques. Reducing these toxic forms of amyloid may slow nerve cell damage and support thinking and memory in early Alzheimer’s disease.
Read Announcement- Drug:
- Lecanemab (BAN2401)
- Announced Date:
- August 28, 2025
- Indication:
- Anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease (AD)
Announcement
FDA to recommend additional, earlier MRI monitoring for patients with Alzheimer’s disease taking Leqembi (lecanemab)
Read Announcement- Drug:
- Lecanemab (BAN2401)
- Announced Date:
- August 25, 2025
- Indication:
- Anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease (AD)
Announcement
Eisai Co., and Biogen Inc. announced today that the anti-amyloid beta (Aβ) monoclonal antibody "LEQEMBI®" has been launched in Austria on August 25, 2025 and will be launched in Germany on September 1, 2025.
AI Summary
Eisai Co., Ltd. and Biogen Inc. announced that LEQEMBI®, their anti-amyloid beta (Aβ) monoclonal antibody for early Alzheimer’s disease (AD), launched in Austria on August 25, 2025, and will launch in Germany on September 1, 2025. This follows European Commission approval in April 2025, making LEQEMBI the first therapy in the EU to target the underlying cause of AD.
LEQEMBI is approved for adults with mild cognitive impairment or mild dementia due to AD who carry zero or one copy of the ApoE ε4 gene and have confirmed brain amyloid. A controlled access program is in place in both countries to ensure safe use. In clinical trials, LEQEMBI reduced cognitive decline by 31% at 18 months compared with placebo and targets both amyloid plaques and toxic protofibrils.
Eisai leads global development and distribution as Marketing Authorization Holder, while Eisai and Biogen will co-promote LEQEMBI across the EU.
Read Announcement- Drug:
- Lecanemab (BAN2401)
- Announced Date:
- July 21, 2025
- Indication:
- Anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease (AD)
Announcement
Biogen Inc. announced upcoming scientific presentations at the 2025 Alzheimer's Association International Conference (AAIC), taking place July 27-31 in Toronto, Canada.
AI Summary
Biogen Inc. announced scientific presentations at the 2025 Alzheimer’s Association International Conference (AAIC) in Toronto from July 27 to 31. Researchers will share 48-month findings from the Clarity AD open-label extension of LEQEMBI (lecanemab) and real-world treatment insights. They will also discuss a new subcutaneous formulation for maintenance dosing, offering a potentially more convenient option for ongoing care. Sessions will include patient, care partner, and healthcare professional feedback on a lecanemab autoinjector and indirect comparisons of imaging outcomes with other therapies.
In addition, Biogen will present data on tau-targeted therapies and biomarkers. Sessions will cover the biological role of tau, advances in targeted treatments, and the integration of these innovations into clinical practice.
Early participant characteristics from the CELIA Phase 2 trial of BIIB080, an investigational antisense oligonucleotide therapy against tau, will also be highlighted. These presentations reflect Biogen’s efforts to improve Alzheimer’s treatment and deepen scientific understanding.
Read Announcement- Drug:
- Lecanemab (BAN2401)
- Announced Date:
- January 31, 2025
- Indication:
- Anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease (AD)
Announcement
Eisai Co and Biogen Inc announced an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as treatment for early AD (mild cognitive impairment due to Alzheimer's disease (AD) and mild AD) in the European Union.
AI Summary
Eisai Co. and Biogen Inc. provided an update on the regulatory review of their Marketing Authorization Application for lecanemab in the European Union. The treatment, aimed at early Alzheimer’s disease—including mild cognitive impairment and mild AD—received a positive opinion from the Committee for Medicinal Products for Human Use in November 2024. However, the European Commission has requested that the CHMP review new safety information that has become available since that opinion was issued, as well as clarify the language on risk minimization measures. These issues are scheduled to be discussed in the upcoming CHMP meeting in February 2025. Both companies remain confident that the additional safety details can be addressed using the existing data and are working closely with authorities to secure approval and deliver lecanemab to patients as soon as possible within the EU.
Read Announcement- Drug:
- Lecanemab (BAN2401)
- Announced Date:
- July 26, 2024
- Indication:
- Anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease (AD)
Announcement
Eisai Co., and Biogen Inc. announced that that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Approval (MAA) for the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody lecanemab as treatment for early AD (mild cognitive impairment due to Alzheimer's disease (AD) and mild AD).1
AI Summary
Eisai Co. and Biogen Inc. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the marketing authorization application for lecanemab. This humanized monoclonal antibody targets soluble aggregated amyloid-beta and is aimed at treating early Alzheimer’s disease, including mild cognitive impairment due to AD and mild AD. The companies expressed disappointment with the decision, emphasizing the significant need for new, effective treatments that address disease progression in Alzheimer’s patients. Despite the setback, Eisai plans to request a re-examination of the CHMP’s opinion and will collaborate with relevant authorities to bring the treatment to eligible patients in the European Union as soon as possible. This decision marks a challenging turn for lecanemab, which is already approved in several other countries.
Read Announcement
Salanersen FDA Regulatory Events
Salanersen is a drug developed by Biogen for the following indication: For the treatment of spinal muscular atrophy (SMA).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- salanersen
- Announced Date:
- March 11, 2026
- Indication:
- For the treatment of spinal muscular atrophy (SMA).
Announcement
Biogen Inc. presented additional results from the Phase 1b study of salanersen, an investigational novel antisense oligonucleotide (ASO) given once a year for spinal muscular atrophy (SMA), at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference.
AI Summary
Biogen presented additional Phase 1b results for salanersen at the 2026 Muscular Dystrophy Association Clinical & Scientific Conference showing one-year data that support the drug’s safety and effectiveness in children with spinal muscular atrophy (SMA) who had room to improve after prior gene therapy. The analysis included 24 participants aged 0.5–12 years who received at least two doses of salanersen (40 mg or 80 mg); the 80 mg dose will be carried forward into Phase 3 studies.
Biogen also unveiled the global Phase 3 program to evaluate once-yearly 80 mg salanersen across a broad SMA population. The program includes STELLAR trials to compare early strategies in presymptomatic newborns—salanersen alone, gene therapy alone, and salanersen as an add-on—and the SOLAR study. STELLAR-1 has begun screening, with SOLAR and STELLAR-2 planned to start in 2026.
Salanersen (BIIB115) is an intrathecal antisense oligonucleotide designed to correct SMN2 splicing and raise SMN protein levels. Its novel backbone chemistry aims to deliver high potency and the potential for once-yearly dosing. These data will also be presented at SMA Europe 2026.
Read Announcement- Drug:
- salanersen
- Announced Date:
- June 25, 2025
- Indication:
- For the treatment of spinal muscular atrophy (SMA).
Announcement
Biogen Inc. announced topline results from the Phase 1 study of salanersen (BIIB115/ION306), an antisense oligonucleotide (ASO) being developed for the treatment of spinal muscular atrophy (SMA).
AI Summary
Biogen Inc. announced promising topline results from its Phase 1 study of salanersen (BIIB115/ION306), a new antisense oligonucleotide aimed at treating spinal muscular atrophy (SMA). The interim data showed that children with SMA who previously received gene therapy experienced a significant slowing of neurodegeneration, as measured by a reduction in neurofilament levels, along with meaningful improvements in motor function. Salanersen, which works similarly to SPINRAZA but is designed for enhanced potency and the convenience of once‐yearly dosing, was tested at both 40 mg and 80 mg doses and was generally well tolerated. Encouraged by these early results, Biogen is collaborating with regulators to plan Phase 3 registrational studies to further evaluate the treatment’s benefits in both previously treated and treatment‐naïve patients.
Read Announcement
Nusinersen FDA Regulatory Timeline and Events
Nusinersen is a drug developed by Biogen for the following indication: In Treatment of spinal muscular atrophy (SMA).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- nusinersen
- Announced Date:
- February 4, 2026
- Indication:
- In Treatment of spinal muscular atrophy (SMA).
Announcement
Biogen Inc. y announced that Nature Medicine published results from the Phase 2/3 DEVOTE study evaluating the high-dose regimen of nusinersen, comprised of 50 mg/5 mL loading and 28 mg/5 mL maintenance doses, in spinal muscular atrophy (SMA).
AI Summary
Biogen reported that Nature Medicine published results from the Phase 2/3 DEVOTE study testing a high‑dose nusinersen regimen for spinal muscular atrophy: two 50 mg/5 mL loading doses 14 days apart, followed by 28 mg/5 mL maintenance every 4 months. The study found the high‑dose approach was safe and effective across ages, baseline function, and prior treatment status, offering a faster loading strategy and higher maintenance exposure than the lower‑dose regimen.
DEVOTE showed clinical benefits including improvements in motor and bulbar function, respiratory health, fewer hospitalizations, and better survival. The high dose produced a faster reduction in neurofilament, a marker of neurodegeneration, than the lower dose. In the pivotal infant cohort, treatment‑naïve infants had a large CHOP‑INTEND gain versus a matched sham group (mean difference 26.19 points; +15.1 vs –11.1, p<0.0001). An open‑label cohort that switched from the lower dose also had functional gains. The safety profile was broadly consistent with known effects, with common adverse events including pneumonia and respiratory failure.
Read Announcement- Drug:
- nusinersen
- Announced Date:
- September 23, 2025
- Indication:
- In Treatment of spinal muscular atrophy (SMA).
Announcement
Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Company's supplemental New Drug Application (sNDA) for the high dose regimen of nusinersen for the treatment of spinal muscular atrophy (SMA).
AI Summary
Biogen Inc. announced that the U.S. Food and Drug Administration issued a Complete Response Letter for its supplemental New Drug Application for a high dose regimen of nusinersen to treat spinal muscular atrophy. The letter asked Biogen to update technical information in the Chemistry, Manufacturing and Controls section but did not question the clinical data supporting the high dose plan. The FDA also outlined options to resolve the request, and Biogen intends to resubmit its application quickly using information already on hand.
“While this outcome was unexpected, we remain committed to bringing the high dose regimen to people living with SMA,” said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. “We are working diligently to provide the necessary information to the FDA.”
Globally, Biogen is working with regulators to advance the high dose option. It was recently approved in Japan and is currently under review by the European Medicines Agency and other agencies around the world.
Read Announcement- Drug:
- nusinersen
- Announced Date:
- January 23, 2025
- Indication:
- In Treatment of spinal muscular atrophy (SMA).
Announcement
Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA)
AI Summary
Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for a higher dose regimen of nusinersen. This new regimen is designed to treat spinal muscular atrophy (SMA) more effectively. It includes a more rapid loading phase with two 50 mg doses given 14 days apart, followed by maintenance doses of 28 mg every four months. This differs from the current approved regimen of 12 mg, which is commercialized under the name SPINRAZA in over 71 countries.
The company believes that the higher dose regimen could offer significant benefits for patients and their families and is a reflection of Biogen’s commitment to advancing new treatment options for SMA. With the sNDA now under review, Biogen looks forward to progressing in providing improved care and potential clinical benefits to the SMA community.
Read Announcement- Drug:
- nusinersen
- Announced Date:
- January 23, 2025
- Indication:
- In Treatment of spinal muscular atrophy (SMA).
Announcement
Biogen Inc. announced that the European Medicines Agency (EMA) has validated the application for a higher dose regimen of nusinersen for spinal muscular atrophy (SMA).
AI Summary
Biogen announced that the European Medicines Agency (EMA) has validated its application for a higher dose regimen of nusinersen for treating spinal muscular atrophy (SMA). This new treatment plan includes a faster loading phase with two 50 mg doses administered 14 days apart, followed by a higher maintenance dose of 28 mg every four months, in contrast to the current 12 mg dose used in SPINRAZA®. Biogen expects that this enhanced regimen could lead to better patient outcomes by delivering higher doses early in treatment while maintaining a similar safety profile.
The EMA validation marks an important step in Biogen’s commitment to improving SMA therapies. With promising results from recent clinical studies, the company is optimistic that the higher dose regimen will provide meaningful benefits, potentially improving the quality of life for individuals and families affected by SMA.
Read Announcement- Drug:
- nusinersen
- Announced Date:
- October 8, 2024
- Indication:
- In Treatment of spinal muscular atrophy (SMA).
Announcement
Biogen Inc. announced detailed results from Part B and Part C of the Phase 2/3 DEVOTE study evaluating the safety and efficacy of an investigational higher dose regimen of nusinersen in spinal muscular atrophy (SMA), showing benefits in both individuals previously treated and treatment-naïve to nusinersen with infantile-onset or later-onset SMA.
AI Summary
Biogen Inc. recently announced detailed results from Parts B and C of the Phase 2/3 DEVOTE study. This study evaluated a higher dose nusinersen regimen for treating spinal muscular atrophy (SMA) in both individuals who were treatment-naïve and those who had previously received nusinersen. The investigational regimen features a faster loading phase with two 50 mg doses given 14 days apart, followed by regular maintenance doses of 28 mg every four months, compared to the approved regimen.
The study results indicate that the higher dose not only improves motor function in infants and older patients but also slows neurodegeneration more rapidly by lowering neurofilament levels, a marker of nerve cell damage. Based on these promising findings, Biogen plans to submit regulatory applications worldwide in hopes of addressing unmet needs in the SMA community.
Read Announcement- Drug:
- nusinersen
- Announced Date:
- September 4, 2024
- Indication:
- In Treatment of spinal muscular atrophy (SMA).
Announcement
Biogen Inc. announced positive, topline data from the pivotal cohort (Part B) of the Phase 2/3 DEVOTE study evaluating the safety and efficacy of a higher dose regimen of nusinersen in treatment-naïve, symptomatic infants with spinal muscular atrophy (SMA).
AI Summary
Biogen announced encouraging topline results from the pivotal Part B cohort of its Phase 2/3 DEVOTE study, which evaluated a higher dose regimen of nusinersen in treatment-naïve, symptomatic infants with spinal muscular atrophy (SMA). The study met its primary endpoint at six months, demonstrating a statistically significant improvement in motor function compared to a matched, untreated sham control group. This investigational regimen features a more rapid loading phase with two 50 mg doses administered 14 days apart, followed by a higher maintenance dose of 28 mg every four months, in contrast to the approved 12 mg dose.
The results also showed favorable trends in key biomarkers and secondary endpoints, suggesting that the higher dose regimen may slow neurodegeneration more effectively. These promising findings support Biogen’s plan to pursue regulatory approval for this enhanced dosing strategy for infants with SMA.
Read Announcement
BIIB059 FDA Regulatory Events
BIIB059 is a drug developed by Biogen for the following indication: Active systemic lupus erythematosus (SLE).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BIIB059
- Announced Date:
- January 28, 2026
- Indication:
- Active systemic lupus erythematosus (SLE)
Announcement
Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for litifilimab (BIIB059) for the treatment of cutaneous lupus erythematosus (CLE).
AI Summary
Biogen Inc. announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for litifilimab (BIIB059) for the treatment of cutaneous lupus erythematosus (CLE). Breakthrough Therapy status is given to investigational medicines that may offer substantial improvement over available treatments for serious conditions and can speed development and review. The designation reflects promising clinical data for litifilimab and could help Biogen advance the drug more quickly toward potential approval for people with CLE.
Litifilimab remains investigational and has not been approved; its safety and effectiveness have not been established. Lupus affects about 90 percent women, often beginning between ages 15 and 40, and disproportionately impacts African American, Asian, American Indian/Alaska Native and Hispanic/Latino communities. There is currently no cure for lupus, so the Breakthrough Therapy Designation offers hope for faster progress in treating the skin manifestations of the disease.
Read Announcement
Felzartamab FDA Regulatory Timeline and Events
Felzartamab is a drug developed by Biogen for the following indication: For the Treatment of Antibody-Mediated Rejection in Kidney Transplant Recipients.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Felzartamab
- Announced Date:
- November 3, 2025
- Indication:
- For the Treatment of Antibody-Mediated Rejection in Kidney Transplant Recipients
Announcement
Biogen Inc. will present new data from its felzartamab clinical development programs at Kidney Week 2025, the American Society of Nephrology's (ASN) annual meeting, taking place November 5-9 in Houston, Texas.
AI Summary
Biogen Inc. will present new data from its felzartamab clinical development programs at Kidney Week 2025, the American Society of Nephrology’s annual meeting, November 5–9 in Houston, Texas. This event offers a chance to share findings from studies exploring felzartamab’s impact in immune-mediated kidney diseases.
The oral presentation will unveil first-of-its-kind longitudinal gene expression data in patients with IgA nephropathy. This RNA sequencing study links gene changes to felzartamab’s mechanism of action and suggests disease-modifying effects. A poster will report preserved humoral immunity after vaccination, indicating a favorable safety profile compared with other B-cell therapies.
An Exhibitor Spotlight will discuss the role of CD38+ cells across kidney diseases, including antibody-mediated rejection and primary membranous nephropathy. Biogen is conducting three Phase 3 studies of felzartamab, with the first data readout expected in 2027. These presentations aim to advance understanding of felzartamab’s potential in nephrology.
Read Announcement- Drug:
- Felzartamab
- Announced Date:
- June 30, 2025
- Indication:
- For the Treatment of Antibody-Mediated Rejection in Kidney Transplant Recipients
Announcement
Biogen Inc. announced the initiation of dosing in the global clinical study, PROMINENT.
AI Summary
Biogen Inc. has begun dosing patients in the global Phase 3 clinical study, PROMINENT. This trial will compare the efficacy and safety of felzartamab, an investigational anti-CD38 monoclonal antibody, with tacrolimus in adults who have primary membranous nephropathy (PMN), a severe, immune-mediated kidney disease. Approximately 180 PMN patients will be enrolled in this study, which is expected to complete readouts in 2029. Felzartamab works by selectively depleting CD38+ plasma cells that produce harmful autoantibodies. By reducing these autoantibodies, the study hopes to achieve complete remission of proteinuria, a key indicator of PMN progression and a risk factor for kidney failure. This trial aims to address the unmet need for an approved, effective treatment in PMN, potentially transforming therapy for patients suffering from this challenging condition.
Read Announcement- Drug:
- Felzartamab
- Announced Date:
- March 11, 2025
- Indication:
- For the Treatment of Antibody-Mediated Rejection in Kidney Transplant Recipients
Announcement
Biogen Inc announced the initiation of dosing in the global clinical study, TRANSCEND.
AI Summary
Biogen Inc has begun dosing patients in its global Phase 3 TRANSCEND study. This trial will compare the investigational drug felzartamab with a placebo in approximately 120 adult kidney transplant recipients diagnosed with late antibody-mediated rejection (AMR), a common cause of transplant failure. TRANSCEND is a 52-week, double-blind, placebo-controlled study designed to evaluate both the efficacy and safety of felzartamab. Early results from a Phase 2 study showed promising first-in-class potential, which has led to the initiation of this larger trial. Biogen hopes that if felzartamab is proven to be effective, it could become a meaningful treatment option for patients suffering from late AMR, ultimately addressing the urgent need for better therapies in kidney transplant care.
Read Announcement- Drug:
- Felzartamab
- Announced Date:
- October 9, 2024
- Indication:
- For the Treatment of Antibody-Mediated Rejection in Kidney Transplant Recipients
Announcement
Biogen Inc. announced that felzartamab, an investigational anti-CD38 monoclonal antibody, has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for the treatment of late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients.
AI Summary
Biogen Inc. announced that its investigational anti-CD38 monoclonal antibody, felzartamab, has received Breakthrough Therapy Designation (BTD) from the U.S. FDA. This designation is intended to accelerate the development and review process for drugs aimed at serious or life-threatening conditions. Felzartamab is being developed to treat late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients—a condition that significantly contributes to transplant failure and represents an unmet medical need. The FDA granted this designation based on promising clinical results that showed the drug’s potential to effectively combat AMR. This status will allow Biogen to work more closely with the FDA and to move efficiently into Phase 3 trials, offering hope of a novel treatment option for kidney transplant recipients facing limited alternatives.
Read Announcement
Dapirolizumab pegol FDA Regulatory Timeline and Events
Dapirolizumab pegol is a drug developed by Biogen for the following indication: In Systemic Lupus Erythematosus.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- dapirolizumab pegol
- Announced Date:
- October 22, 2025
- Indication:
- In Systemic Lupus Erythematosus
Announcement
Biogen Inc. announced upcoming presentations from studies evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate, in systemic lupus erythematosus (SLE) to be presented at the American College of Rheumatology (ACR) Convergence 2025 (October 24-29) in Chicago, Illinois.
AI Summary
Biogen will present dapirolizumab pegol (DZP) at the American College of Rheumatology Convergence 2025 in Chicago. DZP is a novel Fc-free anti-CD40L drug candidate for systemic lupus erythematosus (SLE). Data from the Phase 3 PHOENYCS GO study and preclinical research will be shown.
The Phase 3 PHOENYCS GO study met its primary BICLA endpoint at 48 weeks. Presentations will cover low disease activity, remission, reduced flares, less fatigue and joint pain, and improved quality of life in patients treated with DZP.
Additional preclinical results demonstrate minimal to no human placental transfer of DZP in ex vivo tests and no adverse findings in non-human primates. These data support further research in women before, during, and after pregnancy.
“These presentations strengthen our understanding of the broad effects of dapirolizumab pegol in SLE,” said Diana Gallagher, MD, Head of AD, MS and Immunology Development Units at Biogen. Biogen, in collaboration with UCB, remains focused on advancing its lupus pipeline.
Read Announcement- Drug:
- dapirolizumab pegol
- Announced Date:
- June 12, 2025
- Indication:
- In Systemic Lupus Erythematosus
Announcement
UCB and Biogen Inc today presented additional detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate.
AI Summary
UCB and Biogen Inc. presented new detailed results from the Phase 3 PHOENYCS GO study, which explored the effects of dapirolizumab pegol (DZP), a novel Fc‐free anti-CD40L drug candidate. The study focused on patients with moderate-to-severe systemic lupus erythematosus (SLE) and showed that DZP helped reduce fatigue and improve disease activity. At Week 48, a higher number of patients treated with DZP experienced low or no disease activity than those receiving the standard of care, with improvements seen as early as Week 12. Additionally, key patient-reported outcomes using scales like FACIT-Fatigue indicated a greater benefit for the DZP group. These promising results, presented at the European Alliance of Associations for Rheumatology (EULAR) 2025 meeting in Barcelona, suggest DZP could offer a new option to better manage SLE symptoms and improve patients’ quality of life.
Read Announcement- Drug:
- dapirolizumab pegol
- Announced Date:
- November 19, 2024
- Indication:
- In Systemic Lupus Erythematosus
Announcement
UCB and Biogen Inc. today presented detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate, demonstrating significant clinical improvement in disease activity in people living with moderate-to-severe systemic lupus erythematosus (SLE).
AI Summary
UCB and Biogen Inc. presented detailed results from the Phase 3 PHOENYCS GO study, which evaluated dapirolizumab pegol (DZP), a new anti-CD40L drug candidate, in people with moderate-to-severe systemic lupus erythematosus (SLE). The study met its primary endpoint by showing statistically and clinically significant improvement across all organ systems as measured by the BICLA, a tool that assesses disease activity. Notably, participants receiving DZP along with standard care experienced a 14.6% higher response rate, 50% fewer severe disease flares, and better outcomes on several clinical measures including reduced steroid use. These promising results suggest that DZP, by targeting the CD40L pathway, has the potential to offer a meaningful treatment option for those suffering from this chronic autoimmune disease.
Read Announcement- Drug:
- dapirolizumab pegol
- Announced Date:
- September 24, 2024
- Indication:
- In Systemic Lupus Erythematosus
Announcement
UCB and Biogen Inc. announced positive topline results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol, a novel Fc-free anti-CD40L drug candidate, in people living with moderate-to-severe systemic lupus erythematosus (SLE).
AI Summary
UCB and Biogen Inc. announced positive topline results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol, a novel Fc-free anti-CD40L drug candidate for people with moderate-to-severe systemic lupus erythematosus (SLE). In the study, dapirolizumab pegol, taken alongside standard-of-care treatment, met its primary endpoint by showing significant improvement in disease activity after 48 weeks, as measured by the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA). The trial also showed improvements in key secondary endpoints that tracked disease activity and the frequency of flares.
With these encouraging results, UCB and Biogen are moving forward with further clinical trials, hoping to offer a new treatment option for patients who face limited choices. This progress is a promising step toward addressing the high unmet need in managing SLE, a chronic autoimmune disease that particularly affects women.
Read Announcement
Zuranolone FDA Regulatory Events
Zuranolone is a drug developed by Biogen for the following indication: Major depressive disorder (MDD) and Postpartum depression (PPD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Zuranolone
- Announced Date:
- September 17, 2025
- Indication:
- Major depressive disorder (MDD) and Postpartum depression (PPD)
Announcement
Biogen Inc. announced that the European Commission (EC) has granted marketing authorization for ZURZUVAE® (zuranolone) to treat post-partum depression (PPD) in adults following childbirth.
AI Summary
Biogen Inc. announced that the European Commission has granted marketing authorization for ZURZUVAE® (zuranolone) to treat postpartum depression (PPD) in adults following childbirth in the European Union.
ZURZUVAE is a once-daily, oral, 14-day treatment that represents the first and only therapy approved specifically for PPD in Europe. It is a neuroactive steroid that modulates GABA-A receptors, enhancing inhibitory signals in the brain. In the SKYLARK study, patients treated with ZURZUVAE showed significant relief from depressive symptoms as early as day 3, with benefits sustained through day 45 compared to placebo. Common side effects included somnolence, dizziness, and sedation, and the treatment was generally well tolerated.
This approval addresses an urgent unmet need in maternal health, as up to 20% of women experience PPD after pregnancy and many cases go undiagnosed or untreated. Biogen plans to collaborate with healthcare providers and local authorities to secure timely access for eligible patients across Europe.
Read Announcement- Drug:
- Zuranolone
- Announced Date:
- July 25, 2025
- Indication:
- Major depressive disorder (MDD) and Postpartum depression (PPD)
Announcement
Biogen Inc. announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization for ZURZUVAE® (zuranolone) for the treatment of postpartum depression (PPD) in adults following childbirth.
AI Summary
Biogen Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending marketing authorization for ZURZUVAE® (zuranolone) to treat postpartum depression (PPD) in adults after childbirth. If the European Commission approves it, ZURZUVAE will become the first medicine in the European Union specifically indicated for PPD. The treatment is a once-daily, oral, 14-day course, and data suggest relief of depressive symptoms as early as day three of therapy.
Postpartum depression affects an estimated 5–20% of women after pregnancy and often goes undiagnosed. In the SKYLARK Study, ZURZUVAE met its primary goal by showing a significant drop in depression severity scales at day 15 versus placebo. Key measurements also demonstrated continued symptom reduction through day 45. The medicine was generally well tolerated, with somnolence, dizziness and sedation reported most often. A final decision from the European Commission is expected in the third quarter of 2025.
Read Announcement
BIIB080/IONIS-MAPT FDA Regulatory Events
BIIB080/IONIS-MAPT is a drug developed by Biogen for the following indication: Mild Alzheimer's disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BIIB080/IONIS-MAPT
- Announced Date:
- April 2, 2025
- Indication:
- Mild Alzheimer's disease
Announcement
Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BIIB080, an investigational antisense oligonucleotide (ASO) therapy targeting tau, for the treatment of Alzheimer's disease.
AI Summary
Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational therapy BIIB080. This novel antisense oligonucleotide (ASO) is designed to target tau protein, which plays a key role in Alzheimer’s disease. Fast Track designation is granted to therapies that address serious conditions and unmet medical needs, allowing for a faster review process. Dr. Priya Singhal, Head of Development at Biogen, stated that the FDA’s decision underlines the urgent need for new treatments targeting tau pathology. BIIB080 is the first tau-targeting ASO to move into clinical development for Alzheimer’s disease and is currently being evaluated in a global Phase 2 study, offering hope for innovative treatment options to patients and their families.
Read Announcement
TOFIDENCE FDA Regulatory Events
TOFIDENCE is a drug developed by Biogen for the following indication: For the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TOFIDENCE
- Announced Date:
- September 11, 2024
- Indication:
- For the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.
Announcement
Bio-Thera Solutions, Ltd. announced, in collaboration with Biogen, the publication in the journal Arthritis Research & Therapy of results from Treatment Period 2 (TP2; study weeks 24-48) of a Phase 3 clinical study evaluating BAT1806/BIIB800, an approved biosimilar to Actemra®/RoActemra®3 (tocilizumab). BAT1806/BIIB800 is currently commercialized under the brand name TOFIDENCE™4.
Read Announcement
