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News|Articles|September 28, 2026
Baricitinib Approved for Severe Alopecia Areata in Adolescents
Author(s)Laura Joszt, MA
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Key Takeaways
- FDA labeling now permits baricitinib use in patients aged ≥12 years with severe alopecia areata, expanding access beyond adults to an adolescent population.
- BRAVE-AA-PEDS provided the evidentiary basis for pediatric label expansion of this once-daily oral systemic therapy.
Baricitinib is now FDA approved for adolescents 12 and older with severe alopecia areata, extending the once-daily pill beyond adults.
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Patients as young as 12 years old with severe alopecia areata (AA) can now be prescribed baricitinib (Olumiant; Eli Lilly), a once-daily oral systemic therapy previously approved only for adults with the condition.1 The FDA expanded the drug’s label to patients 12 years and older based on the results of the BRAVE-AA-PEDS study.
As many as 2% of people develop AA in their lifetimes, and nearly 40% of cases begin before age 20, with earlier onset often linked to more extensive hair loss.
“Today's approval marks an important milestone for young people living with severe alopecia areata and their families, who have had limited treatment options to date,” said Adrienne Brown, executive vice president and president, Lilly Immunology. “The visible and often extensive hair loss that comes with severe alopecia areata can have a profound impact on anyone, especially adolescents who are at a pivotal stage of life.”
References
1. FDA approves Lilly's Olumiant (baricitinib) for pediatric patients 12 years of age and older with severe alopecia areata. News release. Eli Lilly. September 25, 2026. Accessed September 28, 2026.
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