FDA Approves Olumiant for Pediatric Severe Alopecia Areata

INDIANAPOLIS, Sept. 25, 2026 /CourierPR/ -- Eli Lilly and Company has expanded the use of its drug Olumiant (baricitinib) to include pediatric patients 12 years of age and older with severe alopecia areata (AA). The U.S. Food and Drug Administration (FDA) approved the medication based on data from the BRAVE-AA-PEDS study, the first and largest Phase 3 trial specifically designed to evaluate the treatment in pediatric patients.

Alopecia areata 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, and nearly 40% of cases occur before the age of 20. Early-onset AA can be more severe and lead to extensive hair loss during adolescence, a formative stage of life.

The FDA approval is based on 36-week data from the adolescent cohort (ages 12 to under 18) of the BRAVE-AA-PEDS study. At baseline, the median Severity of Alopecia Tool (SALT) score was 100, indicating complete scalp hair loss, and patients had been living with AA for a mean of 6.4 years. Treatment with Olumiant resulted in substantial scalp hair regrowth, with 80% or more scalp hair coverage, as measured by a SALT score ≤20, in 42% of patients treated with Olumiant 4 mg and 27% treated with Olumiant 2 mg, compared with 5% receiving placebo. Additionally, 90% or more scalp hair coverage, as measured by a SALT score ≤10, was achieved in 37% of patients treated with Olumiant 4 mg and 21% treated with Olumiant 2 mg, compared with 2% receiving placebo.

The overall safety profile observed in pediatric patients 12 years of age and older with severe AA is consistent with the safety profile in adults with severe AA. Olumiant is available as 4 mg, 2 mg, and 1 mg tablets. The recommended dose is Olumiant 2 mg/day, with an increase to 4 mg/day if treatment response is inadequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, the dosage is to be increased to 4 mg/day. Once an adequate response is achieved on 4 mg/day, the dosage is to be decreased to 2 mg/day.

Since 2017, more than 33,000 patients have been prescribed Olumiant in the U.S. Olumiant is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly. It is available through specialty pharmacies nationwide. In 2022, the FDA approved Olumiant for adult patients with severe AA, making it the first systemic treatment approved in the U.S. for this condition. In April 2026, the European Commission also approved Olumiant for the treatment of adolescents (ages 12 to under 18) with severe AA.

The BRAVE-AA-PEDS study involved 257 adolescent participants who were randomized in a 1:1:1 ratio to receive once-daily placebo, Olumiant 4 mg, or Olumiant 2 mg. The primary endpoint of this study was a SALT score ≤20 (i.e., 80% or more scalp hair coverage) at Week 36. The second cohort of 166 adolescents was randomized 1:1 to Olumiant 4 mg or Olumiant 2 mg to further accumulate safety data.

Eli Lilly and Company is committed to ensuring patients have access to much-needed medicines. Today, Olumiant has coverage at three of the largest pharmacy benefit managers (PBMs) for adults with severe AA. Through Lilly Support Services™ for Olumiant, Lilly offers a patient support program including co-pay assistance for eligible, commercially insured patients.