NOVARTIS PHARMS CORP — Cosentyx FDA Review (NDA/BLA 125504, 2025)
Novartis AG · 2025 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Novartis's Cosentyx (secukinumab) for moderate to severe hidradenitis suppurativa (HS) in adults, based on two Phase 3 trials (M2301 and M2302). Efficacy, primarily measured by HiSCR50, was demonstrated for both 300 mg every 2 weeks (Q2W) and every 4 weeks (Q4W) regimens, with Q2W showing slightly higher efficacy but also increased safety events like fungal infections and inflammatory bowel disease. The FDA recommended a starting dose of 300 mg Q4W, with an option to escalate to Q2W for non-responders. The safety profile was generally consistent with other indications, but specific labeling updates for infections and IBD were advised. Pediatric studies for adolescents were deferred, requiring postmarketing evaluation. The approval included new product presentations and confirmed the suitability of immunogenicity assays.
Key findings — cited to the page
| Incidence rate of Grade 1 and 2 low neutrophil counts | 2.0 % | · p.206 |
| CTCAE Grade ≥2 neutropenia incidence (COSENTYX pediatric) | 11 % | pediatric safety pool · p.19 |
| CTCAE Grade ≥2 neutropenia incidence (Placebo pediatric) | 0 % | · p.20 |
| Incidence rate of Grade 1 and 2 low neutrophil counts | 2.2 % | · p.206 |
| Incidence rate of Grade 1 and 2 low neutrophil counts | 3.4 % | · p.206 |
| CTCAE Grade ≥2 neutropenia incidence (COSENTYX pediatric) | 4 % | · p.20 |
| Pediatric study waiver reason | necessary studies are impossible or highly impracticable as HS typically starts after puberty, and there is a rarity of diagnosis in children aged <12 years of age | Global · p.5 |
| Indication approval | treatment of adult patients with moderate to severe hidradenitis suppurativa | Cosentyx (secukinumab) · Global · p.4 |
| Pediatric study deferral reason | this product is ready for approval for use in adults and the adolescent studies (i.e., PK-based extrapolation) have not been completed | Global · p.5 |
| ASAS20 response, % | 28 % | AS1 Study · p.33 |
| ASAS40 response, % | 36 % | AS1 Study · p.33 |
| Major amendment date | July 10, 2023 | Cosentyx (secukinumab) · Global · p.4 |
Source: Novartis AG ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →