Treats moderate to severe plaque psoriasis (PsO). BLA 761349, held by Novartis Pharms Corp. Secukinumab.
As of Nov 13, 2026, BLA 761349 (Cosentyx), held by Novartis Pharms Corp, was first approved by FDA on Oct 6, 2023, with 10 approved supplements and 0 published complete response letters.
COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 15, 2026 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Oct 6, 2023 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cosentyx150MG · injectable;injection | Secukinumab | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 15, 2026 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Apr 17, 2026 | Supplement 11Labeling · Standard review | Approved | |
| Apr 17, 2026 | Supplement 12Labeling · Standard review | Approved | |
| Mar 12, 2026 | Supplement 10Labeling · Standard review | Approved | |
| Aug 6, 2025 | Supplement 8Labeling · Standard review | Approved | |
| Mar 12, 2025 | Supplement 7Labeling · Standard review | Approved | |
| Oct 4, 2024 | Supplement 5Labeling · Standard review | Approved | |
| Aug 16, 2024 | Supplement 6Labeling · Standard review | Approved | |
| Apr 4, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 21, 2023 | Supplement 4Labeling · Standard review | Approved | |
| Oct 6, 2023 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
