FDAsafety guidance83% confidence
FDA AP — OLUMIANT (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 NDA207924. Sponsor: ELI LILLY AND CO. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: BARICITINIB.
Supporting Context
- Therapeutic area
- Diabetes · GLP-1 Receptor Agonist
- Sub-indication
- General
Related signal: Eli Lilly's LY3457263 Trial in Type 2 Diabetes Shows Potential Against Semaglutide and Tirzepatide