Eli Lilly and Incyte’ Olumiant (baricitinib) Receives the US FDA’s Approval as First-In-Disease Systemic Treatment for Adults with Severe Alopecia Areata
Shots:
- The approval was based on the P-III (BRAVE-AA1 & 2) trials evaluating Olumiant (2/4mg, qd) vs PBO in 1200 adult patients with sev. AA
- The results from both studies showed that 17-22% of patients treated with Olumiant (2mg/day) & 32-35% with 4mg/day achieved ≥80% scalp hair coverage over 3-5% in PBO @36wks.; 11-13% & 24-26% vs 1-4% achieved ≥90% or hair coverage. Under the multiplicity control plan for BRAVE-AA2, the results for Olumiant 2mg/day were not statistically significant
- Improvements in eyebrow & eyelash coverage in patients with 4mg, qd dose @36wks., few patients discontinued treatment due to AEs. Lilly offers Olumiant Together support program to help patients access Olumiant treatment & provides a savings card for eligible commercially insured patients
Ref: Lilly | Image: Eli Lilly
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