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
- Hematology · Myelofibrosis
- Sub-indication
- General
Related signal: Lilly presents promising Phase 1 data for first-in-class type II JAK2 inhibitor in myelofibrosis
Source
FDA document
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