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
Cosentyx, Lutathera, ianalumab, Kisqali®, iptacopan, Rhapsido, and secukinumab. 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.
Cosentyx FDA Regulatory Events
Cosentyx is a drug developed by Novartis for the following indication: in patients with polymyalgia rheumatica.
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:
- Cosentyx
- Announced Date:
- March 13, 2026
- Indication:
- in patients with polymyalgia rheumatica.
Announcement
Novartis announced today that Cosentyx® (secukinumab) received US Food and Drug Administration (FDA) approval for treating pediatric patients 12 years and older with moderate to severe hidradenitis suppurativa (HS), making it the only IL-17A inhibitor for this population1.
Read Announcement- Drug:
- Cosentyx
- Announced Date:
- October 22, 2025
- Indication:
- in patients with polymyalgia rheumatica.
Announcement
Novartis AG shared topline data from the Phase 3 REPLENISH trial of Cosentyx in patients with polymyalgia rheumatica.
Read Announcement
Lutathera FDA Regulatory Events
Lutathera is a drug developed by Novartis for the following indication: 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 under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Lutathera
- Announced Date:
- March 2, 2026
- Indication:
- 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
Lantheus Holdings, Inc. announced that it has received U.S. Food and Drug Administration (FDA) tentative approval for the Abbreviated New Drug Application (ANDA) for Lutetium Lu 177 Dotatate (PNT2003), a radioequivalent1 version of LUTATHERA® (lutetium Lu 177 dotatate).
AI Summary
Lantheus Holdings, Inc. announced it has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Lutetium Lu 177 Dotatate (PNT2003). PNT2003 is described as a radioequivalent version of LUTATHERA® (lutetium Lu 177 dotatate), meaning it matches the reference product’s radioactive drug properties. The tentative approval signals that the FDA’s review of the ANDA is complete and that the submission meets the statutory requirements under the Federal Food, Drug, and Cosmetic Act.
Full approval of the ANDA remains conditional: it is subject to the expiration of a 30-month stay tied to Hatch-Waxman patent litigation, which is set to expire in June 2026. LUTATHERA® is a registered trademark of Novartis AG and/or its affiliates.
Read Announcement
Ianalumab FDA Regulatory Timeline and Events
Ianalumab is a drug developed by Novartis for the following indication: In adults with active Sjögren'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:
- ianalumab
- Announced Date:
- January 16, 2026
- Indication:
- In adults with active Sjögren's disease.
Announcement
Novartis announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ianalumab for Sjögren’s disease, the second most prevalent rheumatic autoimmune disease2. Ianalumab is a fully human monoclonal antibody with a novel dual mechanism of action that depletes B-cells and inhibits their activation and survival via BAFF-R blockade3.
Read Announcement- Drug:
- ianalumab
- Announced Date:
- January 16, 2026
- Indication:
- In adults with active Sjögren's disease.
Announcement
Novartis plans to submit ianalumab for regulatory approval globally starting in early 2026. If approved, ianalumab would become the first targeted treatment for patients with Sjögren’s disease.
Read Announcement- Drug:
- ianalumab
- Announced Date:
- October 29, 2025
- Indication:
- In adults with active Sjögren's disease.
Announcement
Novartis today presented new ianalumab data in Sjögren’s disease, the second most prevalent rheumatic autoimmune disease2, at a late-breaker presentation during the American College of Rheumatology Convergence congress1.
Read Announcement- Drug:
- ianalumab
- Announced Date:
- August 11, 2025
- Indication:
- In adults with active Sjögren's disease.
Announcement
Novartis announced positive top-line results from its Phase III trials evaluating ianalumab (VAY736) in adults with active Sjögren's disease.
AI Summary
Novartis announced positive top-line results from its Phase III NEPTUNUS-1 and NEPTUNUS-2 trials testing ianalumab (VAY736) in adults with active Sjögren’s disease. Both global trials met their primary endpoint by showing statistically significant improvements in disease activity, measured with the EULAR Sjögren’s syndrome disease activity index (ESSDAI), compared with placebo. The studies mark the first time Phase III trials have demonstrated a clear reduction in Sjögren’s disease activity.
Ianalumab is a fully human monoclonal antibody with a dual mechanism of action: it depletes B cells and inhibits BAFF receptor signals. The drug was well tolerated and showed a favorable safety profile across both studies. These findings support ianalumab’s potential to become the first targeted treatment for this chronic, disabling autoimmune condition. Novartis plans to share full data at a medical congress and submit regulatory applications worldwide.
Read Announcement
Kisqali® (ribociclib) FDA Regulatory Events
Kisqali® (ribociclib) is a drug developed by Novartis for the following indication: For breast cancer.
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:
- Kisqali® (ribociclib)
- Announced Date:
- October 17, 2025
- Indication:
- For breast cancer
Announcement
Novartis announced results from the five-year analysis of the pivotal Phase III NATALEE trial of Kisqali® (ribociclib) that demonstrated a sustained benefit at a median of two years after a three-year treatment with Kisqali (median follow-up: 58.4 months). Results showed a 28.4% reduction in risk of recurrence (HR=0.716; 95% CI 0.618-0.829; nominal p-value <0.0001) in the broadest population of patients with high-risk stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) treated with Kisqali plus endocrine therapy (ET) compared to ET alone1.
Read Announcement
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:
- October 16, 2025
- Indication:
- To treat adults with paroxysmal nocturnal hemoglobinuria (PNH).
Announcement
Novartis A/S shared final results from the APPLAUSE-IgAN Phase 3 study evaluating Fabhalta (iptacopan) in adults with IgA nephropathy (IgAN).
Read Announcement- 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
Rhapsido FDA Regulatory Events
Rhapsido is a drug developed by Novartis for the following indication: oral treatment for adult patients with chronic spontaneous urticaria (CSU).
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:
- Rhapsido
- Announced Date:
- September 30, 2025
- Indication:
- oral treatment for adult patients with chronic spontaneous urticaria (CSU)
Announcement
Novartis announced that Rhapsido® (remibrutinib) received US Food and Drug Administration (FDA) approval as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment.
AI Summary
Novartis announced that Rhapsido® (remibrutinib) received FDA approval as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Taken twice daily, Rhapsido is a pill that does not require injections or lab monitoring.
Rhapsido is the first Bruton’s tyrosine kinase inhibitor (BTKi) approved for CSU. By blocking BTK, it stops the release of histamine and other proinflammatory mediators. In Phase III REMIX trials, patients achieved well-controlled disease (UAS7≤6) as early as two weeks, and about one-third reported no hives or itching by Week 12.
CSU affects more than 1.7 million people in the US, and over half stay symptomatic even with higher antihistamine doses. Rhapsido offers a new oral option with a favorable safety profile. The most common side effects were nasal congestion, sore throat, headache and nausea.
Read Announcement
Secukinumab FDA Regulatory 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.
Read Announcement
Vanrafia® (atrasentan) FDA Regulatory 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.
Read Announcement
OAV101 IT FDA Regulatory 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).
Read Announcement
Leqvio FDA Regulatory 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
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