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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 tri...

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