FDAsafety guidance66% confidence
FDA AP — CIBINQO (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (immunology) as Pfizer; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA213871. Sponsor: PFIZER. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: ABROCITINIB.
Supporting Context
- Therapeutic area
- Dermatology · JAK Inhibitor
- Sub-indication
- Immunology
Related signal: FDA Accepts Supplemental NDA for CIBINQO (Abrocitinib) by Pfizer