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FDA approves Lilly's Olumiant for severe alopecia areata in patients 12 and older

25. Sep 2026

(AWP Alliance News) - The FDA cleared Lilly's Olumiant (baricitinib) for pediatric patients aged 12 and older with severe alopecia areata, expanding its US label beyond adults. The decision was backed by 36-week data from the Phase 3 BRAVE-AA-PEDS trial, where 42% of patients on 4 mg reached at least 80% scalp hair coverage versus 5% on placebo.

Lilly said the recommended starting dose is 2 mg once daily, with escalation to 4 mg if response is inadequate.

https://www.prnewswire.com/news-releases/fda-approves-lillys-olumiant-b…

Disclaimer: This news brief was created using generative artificial intelligence. Eli Lilly and Company published the original content used to generate this news brief via PR Newswire on September 25, 2026, and is solely responsible for the information contained therein.

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