Olumiant (baricitinib) - (BRAVE-AA-PEDS)

Sept. 25, 2026: Eli Lilly and Company (NYSE: LLY) said the FDA approved Olumiant (baricitinib) for pediatric patients aged 12 and older with severe alopecia areata, expanding its U.S. label beyond prior adult use.

The approval was supported by 36-week data from the Phase 3 BRAVE-AA-PEDS adolescent cohort, described as the first and largest Phase 3 study designed for pediatric severe alopecia areata. In the first cohort (n=257), baseline median SALT score was 100 and mean disease duration was 6.4 years. At Week 36, SALT ≤20 (80% or more scalp hair coverage) was achieved by 42% with Olumiant 4 mg and 27% with 2 mg versus 5% with placebo; SALT ≤10 (90% or more scalp hair coverage) was achieved by 37% and 21% versus 2%, respectively. Lilly also reported improved eyebrow and eyelash coverage in patients with substantial baseline loss treated with 4 mg.

The company said the pediatric safety profile was consistent with adults with severe alopecia areata. BRAVE-AA-PEDS remains ongoing, including a second adolescent cohort (n=166) randomized to 4 mg or 2 mg to further accumulate safety data.