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

Approval and indication

The U.S. Food and Drug Administration approved Olumiant (baricitinib) for the treatment of pediatric patients 12 years of age and older with severe alopecia areata, expanding the medicine's label beyond adult indications.

BRAVE‑AA‑PEDS trial data

The approval is based on 36‑week data from the adolescent cohort of BRAVE‑AA‑PEDS. At baseline the median SALT score was 100 (complete scalp hair loss) and mean disease duration was 6.4 years. The first cohort randomized 257 adolescents 1:1:1 to placebo, Olumiant 4 mg or Olumiant 2 mg; a second cohort of 166 adolescents was randomized 1:1 to 4 mg or 2 mg. The primary endpoint was a SALT score ≤20 at Week 36.

Efficacy outcomes

At Week 36, 42% of patients on Olumiant 4 mg and 27% on 2 mg reached SALT ≤20 versus 5% on placebo. For SALT ≤10, rates were 37% (4 mg) and 21% (2 mg) versus 2% for placebo. Olumiant 4 mg also produced improvements in eyebrow and eyelash coverage among those with substantial baseline loss.

Dosing, availability and regulatory context

Olumiant is available as 1 mg, 2 mg and 4 mg tablets; the recommended starting dose is 2 mg/day with escalation to 4 mg/day for inadequate response and consideration of 4 mg/day for nearly complete or complete scalp hair loss, then reduction to 2 mg/day after adequate response. Olumiant is a once‑daily oral JAK inhibitor discovered by Incyte and licensed to Lilly; it received prior U.S. approval for adults with severe AA in 2022 and an EU adolescent approval in April 2026.

Safety

The pediatric safety profile was reported as consistent with adults. U.S. labeling carries a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis, and lists common adverse events including infections, headache, acne, laboratory changes and others.