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 supplemental Biologics License Application for Cosentyx (secukinumab) injection, effective October 10, 2023. This approval aligns prescribing information for subcutaneous and intravenous (IV) routes, specifically for adult active psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. The IV formulation, developed using a Model-Informed Drug Development approach, leverages pharmacokinetic bridging and extrapolation from the established subcutaneous formulation's efficacy and safety. Clinical studies demonstrated significant improvements in ASAS40 response for axial spondyloarthritis and ACR50 response for psoriatic arthritis compared to placebo. The safety profile, including common adverse reactions like infections and concerns such as inflammatory bowel disease exacerbations, remains consistent across formulations. Dosage recommendations, storage, and disposal instructions are provided for various administration devices. A postmarketing study is mandated for pediatric psoriatic arthritis patients.
Key findings — cited to the page
| Neutrophil abnormalities Grade 3 (secukinumab group) | 0.4 % | Study P12301 · p.166 |
| Neutrophil abnormalities Grade 1 (secukinumab group) | 8.5 % | Study P12301 · p.166 |
| Neutrophil abnormalities Grade 1 (placebo group) | 1.2 % | Study P12301 · p.166 |
| Neutrophil abnormalities Grade 3 (placebo group) | 0.4 % | Study P12301 · p.166 |
| Neutrophil abnormalities Grade 2 (placebo group) | 1.6 % | Study P12301 · p.166 |
| Neutrophil abnormalities Grade 2 (secukinumab group) | 2.3 % | Study P12301 · p.166 |
| Indication for active psoriatic arthritis (PsA) | 2 years of age and older | COSENTYX · p.9 |
| PASI 75 response | 83 % | Trial PsO7 · p.26 |
| IGA of clear or almost clear | 65 % | Trial PsO1 · p.25 |
| Approval for intravenous use in active ankylosing spondylitis | Approved | Cosentyx (secukinumab) · p.4 |
| Approval for intravenous use in active non-radiographic axial spondyloarthritis | Approved | Cosentyx (secukinumab) · p.4 |
| Intravenous dosage for adult psoriatic arthritis (without loading dose) | 1.75 mg/kg every 4 weeks | COSENTYX · p.9 |
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 →