FDAsafety guidance72% confidence
FDA AP — DUPIXENT (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (immunology) as Regeneron.
Regulatory Analysis
Application BLA761055. Sponsor: REGENERON PHARMACEUTICALS. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: DUPILUMAB.
Supporting Context
- Therapeutic area
- Dermatology · Autoimmune Disease
- Sub-indication
- Immunology
Related signal: Regeneron and Sanofi Study Dupilumab for Bullous Pemphigoid in Adults