FDAsafety guidance66% confidence
FDA AP — SKYRIZI (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for AbbVie; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application BLA761105. Sponsor: ABBVIE INC. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: RISANKIZUMAB-RZAA.
Supporting Context
- Therapeutic area
- Immunology · IL-23
- Sub-indication
- General
Related signal: FDA Accepts Supplement Application for SKYRIZI (Risankizumab) by AbbVie