FDAsafety guidance66% confidence
FDA AP — VYEPTI (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Bayer Healthcare Pharmaceuticals; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application BLA761119. Sponsor: Lundbeck Seattle BioPharmaceuticals, Inc.. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: EPTINEZUMAB-JJMR.
Supporting Context
- Therapeutic area
- Not specified
- Sub-indication
- General
Related signal: Bayer's NDA219627 Receives Approval from FDA