FDAsafety guidance72% confidence
FDA AP — EBGLYSS (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Eli Lilly.
Regulatory Analysis
Application BLA761306. Sponsor: ELI LILLY AND CO. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: LEBRIKIZUMAB-LBKZ.
Supporting Context
- Therapeutic area
- Endocrinology · Type 2 Diabetes
- Sub-indication
- General
Related signal: Lilly's Foundayo shows superior results in Phase 3 trial for type 2 diabetes