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Lilly's Olumiant Is First Drug FDA Approved For Alopecia Areata

 
• By Jessica Merrill

The FDA approved baricitinib for the hair loss disorder despite safety concerns with JAK inhibitors. It carries the same warnings on risk of CV events and malignancy as the others in the class.

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Lilly is the first to market with a drug for alopecia areata • Source: Shutterstock

The US Food and Drug Administration approved Eli Lilly and Company's JAK inhibitor Olumiant (baricitinib) for the treatment of severe alopecia areata, marking the first systemic treatment approved for the disorder that can cause patchy baldness. With the 13 June approval, Lilly beat a close rival, Pfizer Inc., to the market.

The FDA approved Olumiant for rheumatoid arthritis in 2018, but the drug has faced a challenging commercial market due to safety concerns with the JAK inhibitor class generally, but also with Olumiant specifically. Those concerns resulted in only the lower 2mg dose being approved for RA, a dose that delivered relatively modest efficacy. (Also see "Lilly Prices Olumiant For JAK Battle, But Misses Approval For Higher Dose" - Scrip, 2 June, 2018

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