FDAsafety guidance66% confidence
FDA AP — EBGLYSS (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (immunology) as Eli Lilly; the same agency is already in play for this signal, so precedent weight is higher.
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
- Dermatology · Atopic Dermatitis
- Sub-indication
- Immunology
Related signal: FDA approves Lilly's EBGLYSS® for atopic dermatitis with unique dosing regimen