FDA approves Lilly’s Olumiant for adolescents with severe alopecia areata

The U.S. Food and Drug Administration has approved Eli Lilly’s Olumiant, also known as baricitinib, for the treatment of patients aged 12 years and older with severe alopecia areata.

The approval expands the U.S. label for the once daily oral treatment, which is already used in adults with severe alopecia areata and moderately to severely active rheumatoid arthritis.

Alopecia areata is a chronic immune mediated condition that causes unpredictable hair loss. Up to 2% of people develop the disease at some point in their lives, while nearly 40% of cases begin before the age of 20.

Lilly said alopecia areata beginning earlier in life can be more severe and may lead to extensive hair loss.

Adrienne Brown, Executive Vice President and President of Lilly Immunology, said the approval provides an additional treatment option for adolescents with severe alopecia areata, a group that has historically had limited choices.

She said extensive and visible hair loss can have a significant impact during adolescence and that expanding Olumiant to patients aged 12 and older represents an important step in Lilly’s work in immune mediated diseases.

The FDA decision is supported by 36 week findings from the adolescent cohort of the Phase III BRAVE AA PEDS study.

BRAVE AA PEDS is the first and largest Phase III trial specifically designed to evaluate paediatric patients with severe alopecia areata.

Participants in the adolescent cohort were aged from 12 to under 18 years.

At the beginning of the study, the median Severity of Alopecia Tool score was 100, indicating complete scalp hair loss. Patients had been living with alopecia areata for an average of 6.4 years.

At week 36, 42% of patients receiving Olumiant 4 mg achieved at least 80% scalp hair coverage, defined as a SALT score of 20 or lower.

This compared with 27% of patients treated with the 2 mg dose and 5% of those receiving placebo.

At least 90% scalp hair coverage, represented by a SALT score of 10 or lower, was achieved by 37% of patients taking Olumiant 4 mg and 21% receiving 2 mg, compared with 2% in the placebo group.

Patients who had substantial eyebrow and eyelash hair loss at baseline also experienced improvements in coverage when treated with Olumiant 4 mg.

The overall safety profile observed in patients aged 12 and older was consistent with the established safety profile of Olumiant in adults with severe alopecia areata.

The U.S. prescribing information carries a boxed warning covering risks including serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis.

Brittany Craiglow, MD, Adjunct Associate Professor of Dermatology at Yale School of Medicine, said severe alopecia areata beginning early in life can become more extensive and difficult to treat.

She said evidence from a Phase III study specifically designed for paediatric patients could help clinicians and families make more informed treatment decisions.

Olumiant is available in 1 mg, 2 mg and 4 mg tablets.

The recommended starting dose is 2 mg once daily, with the option to increase to 4 mg when the treatment response is inadequate.

For patients with almost complete or complete scalp hair loss, with or without substantial eyebrow or eyelash involvement, treatment with 4 mg may be considered. Once an adequate response is achieved, the dose can be reduced to 2 mg.

Olumiant is an oral JAK inhibitor discovered by Incyte and licensed to Lilly.

The FDA first approved Olumiant for adults with severe alopecia areata in 2022, making it the first systemic treatment approved in the U.S. for the condition.

The European Commission also approved Olumiant in April 2026 for adolescents aged 12 to under 18 years with severe alopecia areata.

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