This section highlights FDA-related milestones and regulatory updates for drugs developed by Novartis (NVS).
Over the past two years, Novartis has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BIMZELX, Coartem, iptacopan, Leqvio, Lutathera, OAV101, and secukinumab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
BIMZELX (bimekizumab) - FDA Regulatory Timeline and Events
BIMZELX (bimekizumab) is a drug developed by Novartis for the following indication: Moderate to Severe Plaque Psoriasis.
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:
- BIMZELX (bimekizumab)
- Announced Date:
- April 4, 2024
- Indication:
- Moderate to Severe Plaque Psoriasis
Announcement
UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for BIMZELX® (bimekizumab-bkzx), an IL-17A and IL-17F inhibitor, for the treatment of adults with moderate-to-severe hidradenitis suppurativa (HS).
Read Announcement- Drug:
- BIMZELX (bimekizumab)
- Announced Date:
- April 4, 2024
- Indication:
- Moderate to Severe Plaque Psoriasis
Announcement
UCB, a global biopharmaceutical announced that a second sBLA for the BIMZELX 2mL device presentations has also been accepted.
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Coartem - FDA Regulatory Timeline and Events
Coartem is a drug developed by Novartis for the following indication: treatment for babies <5 kg with malaria.
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:
- Coartem
- Announced Date:
- April 24, 2024
- Indication:
- treatment for babies <5 kg with malaria
Announcement
Novartis and Medicines for Malaria Venture announce positive data from their phase II/III CALINA study, demonstrating that a novel formulation of Coartem® (artemether-lumefantrine) developed for babies weighing less than 5kg with malaria has the required pharmacokinetic profile and good efficacy and safety
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iptacopan - FDA Regulatory Timeline and Events
iptacopan is a drug developed by Novartis for the following indication: To treat adults with paroxysmal nocturnal hemoglobinuria (PNH).
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:
- iptacopan
- Announced Date:
- March 20, 2025
- Indication:
- To treat adults with paroxysmal nocturnal hemoglobinuria (PNH).
Announcement
Novartis announced that oral Fabhalta® (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria, making it the first and only treatment approved for this condition1-4.
AI Summary
Novartis announced that the U.S. FDA has approved Fabhalta® (iptacopan), an oral treatment for reducing proteinuria in adults with complement 3 glomerulopathy (C3G). This rare kidney disease can lead to kidney failure and has long had limited treatment options. Fabhalta becomes the first and only approved therapy that targets the disease’s underlying cause by selectively inhibiting the alternative complement pathway.
The approval is based on a Phase III study that showed significant and sustained proteinuria reduction over one year with a favorable safety profile. With Fabhalta now available, patients with C3G have a new treatment option that goes beyond supportive care and broad immunosuppression, offering hope for better management and an improved quality of life.
Read Announcement- Drug:
- iptacopan
- Announced Date:
- December 6, 2024
- Indication:
- To treat adults with paroxysmal nocturnal hemoglobinuria (PNH).
Announcement
Novartis AG revealed topline results from the APPULSE-PNH Phase 3B study of Fabhalta (iptacopan) in adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who were switched from anti-C5 therapies (Hb ≥10g/dL following treatment with eculizumab or ravulizumab).
AI Summary
Novartis AG announced topline results from the APPULSE-PNH Phase 3B study evaluating Fabhalta (iptacopan) in adults with paroxysmal nocturnal hemoglobinuria (PNH). The study focused on patients who had already been treated with anti-C5 therapies such as eculizumab or ravulizumab and had baseline hemoglobin levels of at least 10 g/dL. After 24 weeks of treatment with Fabhalta, researchers observed an improvement in the average hemoglobin levels compared to baseline. The safety profile of Fabhalta monotherapy was in line with previously reported data, reinforcing its potential as an effective treatment option for PNH patients transitioning from anti-C5 therapies. Novartis plans to present detailed results at a medical meeting in 2025, which may further clarify the role of Fabhalta in managing this rare, complement-mediated blood disorder.
Read Announcement- Drug:
- iptacopan
- Announced Date:
- April 15, 2024
- Indication:
- To treat adults with paroxysmal nocturnal hemoglobinuria (PNH).
Announcement
Novartis today presented results from a pre-specified interim analysis of the Phase III APPLAUSE-IgAN study of Fabhalta® (iptacopan), an investigational Factor B inhibitor of the alternative complement pathway, in patients with IgA nephropathy (IgAN)1.
AI Summary
Novartis presented promising results from a pre-specified interim analysis of the Phase III APPLAUSE-IgAN study in patients with IgA nephropathy (IgAN). The study evaluated Fabhalta® (iptacopan), an investigational Factor B inhibitor that targets the alternative complement pathway responsible for glomerular inflammation. Patients treated with Fabhalta experienced a significant 38.3% reduction in proteinuria at 9 months compared to those on placebo, a key finding since proteinuria reduction is an important marker linked to kidney failure progression.
The interim analysis, which included over 250 patients for efficacy and more than 440 for safety, also confirmed Fabhalta’s favorable safety profile. These positive results support Fabhalta’s potential as a targeted therapy to slow IgAN progression and have contributed to its submission for accelerated FDA approval, highlighting a promising development for patients with this progressive kidney disease.
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Leqvio - FDA Regulatory Timeline and Events
Leqvio is a drug developed by Novartis for the following indication: To enable earlier use in patients with elevated LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy1.
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:
- Leqvio
- Announced Date:
- August 28, 2024
- Indication:
- To enable earlier use in patients with elevated LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy1.
Announcement
Novartis announced positive topline results from twice-yearly* Leqvio® (inclisiran) in the Phase III V-MONO study, which met its primary endpoints. Leqvio monotherapy achieved clinically meaningful and statistically significant low-density lipoprotein cholesterol (LDL-C) lowering versus both placebo and ezetimibe in patients who were at low or moderate risk of developing atherosclerotic cardiovascular disease (ASCVD) and not receiving lipid-lowering therapy1.
Read Announcement- Drug:
- Leqvio
- Announced Date:
- April 6, 2024
- Indication:
- To enable earlier use in patients with elevated LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy1.
Announcement
Novartis announced new data demonstrating the early addition of twice-yearly* Leqvio® (inclisiran) to maximally tolerated statin therapy, prior to guideline-recommended ezetimibe, in a real-world setting significantly reduced low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD), including those with a history of an ASCVD-related event, who could not reach their goal on statin therapy alone1.
AI Summary
Novartis has released new data from the V-INITIATE trial showing that adding twice-yearly Leqvio® (inclisiran) early to maximally tolerated statin therapy can significantly reduce LDL cholesterol in patients with atherosclerotic cardiovascular disease (ASCVD). This real‑world study focused on patients who were unable to reach their LDL‑C goals with statins alone. In the trial, patients who received Leqvio experienced a 60% reduction in LDL‑C compared to just a 7% reduction among those who received usual care, which primarily relied on statin therapy. This early intervention was done before guideline-recommended treatment with ezetimibe, indicating that starting non‑statin therapy sooner could help more patients, including those with a history of ASCVD‐related events, achieve their cholesterol targets.
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Lutathera - FDA Regulatory Timeline and Events
Lutathera is a drug developed by Novartis for the following indication: s for the treatment of SSTR-positive GEP-NETs, including foregut, midgut and hindgut neuroendocrine tumors in adults and in Europe for unresectable or metastatic, progressive, well-differentiated (G1 and G2), SSTR-positive GEP-NETs in adults10-11 .
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:
- Lutathera
- Announced Date:
- April 23, 2024
- Indication:
- s for the treatment of SSTR-positive GEP-NETs, including foregut, midgut and hindgut neuroendocrine tumors in adults and in Europe for unresectable or metastatic, progressive, well-differentiated (G1 and G2), SSTR-positive GEP-NETs in adults10-11 .
Announcement
Novartis AG received FDA approval for its Lutathera (lutetium Lu 177 dotatate / INN: lutetium (177Lu) oxodotreotide) for pediatric patients 12 years and older with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs.
AI Summary
Novartis AG recently received FDA approval for Lutathera (lutetium Lu 177 dotatate), a targeted radiopharmaceutical therapy, now available for pediatric patients aged 12 and older. This approval covers treatment for those with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs. The therapy is designed to deliver localized radiation directly to tumor cells that express somatostatin receptors, helping to reduce tumor size while minimizing damage to surrounding healthy tissue. This milestone marks a significant advancement in offering a precision treatment option for young patients with these rare cancers. Novartis’ commitment to expanding innovative treatment choices is further underscored by this approval, which aims to improve patient outcomes and quality of life in a population with significant unmet medical needs.
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OAV101 IT - FDA Regulatory Timeline and Events
OAV101 IT is a drug developed by Novartis for the following indication: In Patients With Spinal Muscular Atrophy.
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:
- OAV101 IT
- Announced Date:
- March 19, 2025
- Indication:
- In Patients With Spinal Muscular Atrophy
Announcement
Novartis AG announced safety and efficacy results from the Phase 3 program for investigational intrathecal onasemnogene abeparvovec (OAV101 IT) in a broad population of patients aged two to <18 years with spinal muscular atrophy (SMA).
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secukinumab - FDA Regulatory Timeline and Events
secukinumab is a drug developed by Novartis for the following indication: In adults with newly diagnosed or relapsing giant cell arteritis (GCA).
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:
- secukinumab
- Announced Date:
- July 3, 2025
- Indication:
- In adults with newly diagnosed or relapsing giant cell arteritis (GCA).
Announcement
Novartis announced top-line results from the Phase III GCAptAIN study evaluating Cosentyx® (secukinumab) in adults with newly diagnosed or relapsing giant cell arteritis (GCA).
AI Summary
Novartis announced top-line Phase III results from the GCAptAIN study, which evaluated Cosentyx® (secukinumab) in adults with newly diagnosed or relapsing giant cell arteritis (GCA). The study compared Cosentyx in combination with a 26‑week steroid taper against a placebo with a 52‑week steroid taper. Unfortunately, the trial did not meet its primary endpoint of achieving sustained remission at Week 52. Although the secondary outcomes were not statistically significant, Cosentyx showed numerically better results compared to placebo in reducing the cumulative steroid dose and lowering steroid-related toxicity.
The safety profile observed in GCA patients was consistent with Cosentyx’s known safety data from its 10 years of real-world use. Despite the unmet primary endpoint, Novartis remains committed to advancing scientific research in immune-mediated diseases and plans to fully evaluate and share more details from the GCAptAIN study soon.
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Vanrafia® (atrasentan) - FDA Regulatory Timeline and Events
Vanrafia® (atrasentan) is a drug developed by Novartis for the following indication: In adults with primary immunoglobulin A nephropathy (IgAN).
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:
- Vanrafia® (atrasentan)
- Announced Date:
- April 2, 2025
- Indication:
- In adults with primary immunoglobulin A nephropathy (IgAN)
Announcement
Novartis announced the US Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia® (atrasentan), a potent and selective endothelin A (ETA) receptor antagonist, for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.
AI Summary
Novartis announced that the US Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia® (atrasentan), a potent and selective endothelin A receptor antagonist, to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of rapid disease progression. This approval is based on a prespecified interim analysis from the Phase III ALIGN study, which demonstrated a statistically significant proteinuria reduction of over 36% compared with placebo. Vanrafia is a once-daily, non-steroidal oral treatment that can be seamlessly added to existing supportive care regimens, including the use of renin-angiotensin system (RAS) inhibitors, with or without sodium-glucose co-transporter-2 (SGLT2) inhibitors, and does not require a REMS program. Although further studies are ongoing to verify if Vanrafia can slow kidney function decline, this decision provides a promising new treatment option for patients suffering from IgAN.
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