FDAsafety guidance66% confidence
FDA AP — ENSPRYNG (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ophthalmology) as Roche; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application BLA761149. Sponsor: GENENTECH. Submission status: AP. Submission type: SUPPL. Review priority: N/A. Active ingredients: SATRALIZUMAB.
Supporting Context
- Therapeutic area
- Ophthalmology · Thyroid Eye Disease
- Sub-indication
- Ophthalmology
Related signal: FDA Grants Priority Review for Roche's Enspryng in Thyroid Eye Disease