FDAsafety guidance83% confidence
FDA AP — VYEPTI (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to KSHB Biopharma.
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
- Rheumatology · Biologic
- Sub-indication
- General
Related signal: KSHB002 Trial Shows Equivalence to ORENCIA in PK, Safety, and Immunogenicity for RA