FDAsafety guidance66% confidence
FDA AP — OCREVUS (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ophthalmology) as Genentech; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application BLA761053. Sponsor: GENENTECH INC. Submission status: AP. Submission type: SUPPL. Review priority: PRIORITY. Active ingredients: OCRELIZUMAB.
Supporting Context
- Therapeutic area
- Ophthalmology · Anti-VEGF
- Sub-indication
- Ophthalmology
Related signal: FDA Accepts Supplement for VABYSMO by Genentech