FDAsafety guidance66% confidence
FDA AP — COSENTYX (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Novartis; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application BLA125504. Sponsor: NOVARTIS PHARMS CORP. Submission status: AP. Submission type: SUPPL. Review priority: PRIORITY. Active ingredients: SECUKINUMAB.
Supporting Context
- Therapeutic area
- Immunology · IL-17
- Sub-indication
- General
Related signal: FDA Approves Supplemental Application for Cosentyx (Secukinumab)