FDAsafety guidance66% confidence
FDA AP — SOLIRIS (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Alexion; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application BLA125166. Sponsor: ALEXION PHARM. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: ECULIZUMAB.
Supporting Context
- Therapeutic area
- Immunology · Complement Inhibition
- Sub-indication
- General
Related signal: FDA Acceptance of Supplement for BLA761340 by Samsung Bioepis