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Eli Lilly and Incyte’ Olumiant (baricitinib) Receives the US FDA’s Approval as First-In-Disease Systemic Treatment for Adults with Severe Alopecia Areata

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Eli Lilly and Incyte’ Olumiant (baricitinib) Receives the US FDA’s Approval as First-In-Disease Systemic Treatment for Adults with Severe Alopecia Areata

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  • 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 

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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