FDAsafety guidance83% confidence
FDA AP — DUPIXENT (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Centessa Pharmaceuticals.
Regulatory Analysis
Application BLA761055. Sponsor: REGENERON PHARMACEUTICALS. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: DUPILUMAB.
Supporting Context
- Therapeutic area
- Neurology · Narcolepsy
- Sub-indication
- General
Related signal: Cleminorexton Study for Narcolepsy Type 1 and Type 2 Initiated by Centessa Pharmaceuticals