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Lilly’s Olumiant Becomes First FDA-approved Treatment for Alopecia Areata

Approval based on Lilly's BRAVE-AA1 and BRAVE-AA2 trials, the largest Phase 3 clinical trial program in Alopecia Areata to date.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Eli Lilly and Co. and Incyte received approval from the FDA for OLUMIANT (baricitinib), a once-daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata (AA), available as 4-mg, 2-mg and 1-mg tablets. OLUMIANT is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
 
The approval was based on Lilly’s BRAVE-AA1 and BRAVE-AA2 trials, the largest Phase 3 AA clinical trial program completed to date, evaluating the efficacy and safety of OLUMIANT in 1,200 adult patients with severe AA (≥50% scalp hair loss as defined by a Severity of Alopecia Tool (SALT) score ≥50).
 
Across the studies at 36 weeks, 17-22% of patients taking OLUMIANT 2-mg/day and 32-35% of patients taking OLUMIANT 4-mg/day achieved 80% or more scalp hair coverage, compared to 3-5% taking placebo. Additionally, 11-13% of patients taking OLUMIANT 2-mg/day and 24-26% of patients taking OLUMIANT 4-mg/day achieved 90% or more hair coverage, compared to 1-4% of patients taking placebo.
 
Among patients with substantial eyebrow and eyelash hair loss at baseline, improvements in eyebrow and eyelash coverage were seen for patients taking OLUMIANT 4-mg daily at 36 weeks.
 
 
 
 

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