The US Food and Drug Administration has approved Olumiant for children aged 12 and over with severe alopecia areata, extending use of the once-daily pill to younger patients.
Alopecia areata is a condition in which the immune system attacks hair follicles, causing unpredictable hair loss. In severe cases, children can lose most or all of their scalp hair, as well as their eyebrows and eyelashes. Olumiant, also known as baricitinib, was already approved in the US for adults with severe alopecia areata. olumiant.lilly.com
The expanded approval is supported by results from BRAVE-AA-PEDS, a Phase 3 trial designed to assess the treatment in children with severe alopecia areata. The data submitted for the decision came from participants aged 12 to under 18.
Hair loss was extensive when those adolescents entered the study. Their median Severity of Alopecia Tool score was 100, indicating complete scalp hair loss, and they had been living with alopecia areata for an average of 6.4 years. The tool measures how much of the scalp is affected, allowing researchers to assess changes during treatment.
After 36 weeks, 42 per cent of adolescents taking a 4 mg daily dose of Olumiant had at least 80 per cent scalp hair coverage. The same result was seen in 27 per cent of those taking 2 mg and five per cent of those given a placebo.
At least 90 per cent scalp hair coverage was recorded in 37 per cent of the 4 mg group and 21 per cent of the 2 mg group, compared with two per cent of the placebo group. The study also found improved eyebrow and eyelash coverage among some participants taking 4 mg who had substantial hair loss in those areas at the start.
Eli Lilly, which markets Olumiant, said the safety profile observed in the adolescent study was consistent with that seen in adults with severe alopecia areata. The drug’s US label nevertheless carries a boxed warning for serious infections, death, cancer, major cardiovascular events and blood clots. These risks are an important part of discussions between clinicians, young people and their families when considering treatment. olumiant.lilly.com
The recommended starting dose is 2 mg a day. Under the US prescribing information described by Lilly, clinicians may increase it to 4 mg if the response is inadequate. A 4 mg dose may also be considered for patients with nearly complete or complete scalp hair loss. Once an adequate response is achieved at that dose, it is reduced to 2 mg.
The decision gives clinicians another treatment option for adolescents with severe disease. It does not establish that every young person will respond: even at the higher dose, fewer than half of participants reached the trial’s threshold of 80 per cent scalp coverage after 36 weeks.
Olumiant is a Janus kinase, or JAK, inhibitor. It works by blocking signals involved in the immune response. The FDA first approved it for adults with severe alopecia areata in 2022; the European Commission approved its use for adolescents with severe alopecia areata in April 2026.