Eli Lilly's Olumiant Gets FDA Approval for Severe Alopecia Areata in Adolescents

04:09 AM EDT, 09/28/2026 (MT Newswires) -- Eli Lilly (LLY) said Friday the US Food and Drug Administration approved its drug, Olumiant, for patients ages 12 and older with severe alopecia areata, expanding its US approval to adolescents. The approval was based on 36-week data from a Phase 3 trial. The company said the approval was based on a phase 3 trial that showed 42% of patients taking 4 mg and 27% taking 2 mg achieved at least 80% scalp hair coverage, compared with 5% on placebo. The drug carries an FDA boxed warning for serious infections, cancer, major cardiovascular events, blood clots, and death, Lilly said.