FDAsafety guidance72% confidence
FDA AP — ULTOMIRIS (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to AstraZeneca.
Regulatory Analysis
Application BLA761108. Sponsor: ALEXION PHARM. Submission status: AP. Submission type: SUPPL. Review priority: N/A. Active ingredients: RAVULIZUMAB-CWVZ.
Supporting Context
- Therapeutic area
- Nephrology · Complement Inhibition
- Sub-indication
- General
Related signal: Ultomiris meets primary endpoint in Phase III trial for IgAN