The US Food and Drug Administration (FDA) has approved Olumiant (baricitinib) for patients aged 12 years and older with severe alopecia areata, expanding the treatment’s existing approval for adults with the condition.

Developed by Eli Lilly, the once-daily oral JAK inhibitor received the expanded approval based on findings from the BRAVE-AA-PEDS Phase 3 trial, which was specifically designed to evaluate adolescents with severe alopecia areata.

At Week 36, 42% of patients receiving Olumiant 4 mg and 27% receiving 2 mg achieved at least 80% scalp hair coverage, compared with 5% among those receiving placebo. For at least 90% scalp coverage, the corresponding rates were 37%, 21% and 2%.

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The study also reported improvements in eyebrow and eyelash coverage among patients who had substantial hair loss in these areas at baseline.

“Alopecia areata can affect much more than hair, particularly during adolescence, when young people are navigating important personal and social milestones,” said George Gondo, chief mission officer, National Alopecia Areata Foundation. “More treatment choices mean more families have the opportunity to find the option that’s right for their child, together with their doctor.”

Alopecia areata is a chronic immune-mediated condition that can cause unpredictable hair loss and may have an extensive impact when it begins during adolescence.

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The FDA-approved prescribing information includes a boxed warning covering serious infections, malignancy, major cardiovascular events, thrombosis and mortality risks.