FDA approval supported by data from BRAVE-AA-PEDS, the first and largest Phase 3 study specifically designed to evaluate pediatric patients with severe alopecia areata (AA)

Treatment with Olumiant resulted in substantial scalp hair regrowth, as well as improvements in eyebrows and eyelashes

Severe AA can result in extensive hair loss during adolescence, a formative stage of life

INDIANAPOLIS, Sept. 25, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) announced today that the U.S. Food and Drug Administration (FDA) approved Olumiant (baricitinib), a once-daily pill, for the treatment of pediatric patients 12 years of age and older with severe alopecia areata (AA).1 The approval expands Olumiant's U.S. label, building on its established use in adults with moderately to severely active rheumatoid arthritis and severe AA.

AA is a chronic immune-mediated disease that causes unpredictable hair loss. As many as 2% of people develop AA at some point in their lives,2 and nearly 40% of cases occur before the age of 20.3 Early-onset AA can be more severe and lead to extensive hair loss.3