FDAsafety guidance72% confidence
FDA AP — SKYRIZI (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Janssen.
Regulatory Analysis
Application BLA761105. Sponsor: ABBVIE INC. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: RISANKIZUMAB-RZAA.
Supporting Context
- Therapeutic area
- Gastroenterology · Crohn's Disease
- Sub-indication
- General
Related signal: Janssen's Guselkumab Compared to Risankizumab in Crohn's Disease Study Initiated