Olumiant Gains FDA Approval for Severe Alopecia Areata in Patients 12 and Older
Key Takeaways
- The FDA expanded Olumiant (baricitinib) to patients aged 12 years and older with severe alopecia areata (AA).
- In BRAVE-AA-PEDS, 42% of adolescents receiving baricitinib 4 mg and 27% receiving 2 mg achieved a SALT score ≤20 at Week 36, compared with 5% receiving placebo.
- The pediatric safety profile was consistent with the established adult severe AA profile; Olumiant carries a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
The FDA has approved Eli Lilly and Company’s Olumiant (baricitinib) for patients aged 12 years and older with severe alopecia areata (AA), expanding the oral Janus kinase (JAK) inhibitor’s US indication to adolescents, according to an announcement from the manufacturer. The drug was previously approved for adults with severe AA.
The approval was supported by 36-week results from the adolescent cohort of BRAVE-AA-PEDS, a phase 3 study evaluating baricitinib in pediatric patients with severe AA. The trial’s primary endpoint was achievement of a Severity of Alopecia Tool (SALT) score of 20 or lower, corresponding to at least 80% scalp hair coverage. At baseline, adolescents had a median SALT score of 100, indicating complete scalp hair loss, and had lived with AA for a mean of 6.4 years.
BRAVE-AA-PEDS Shows Scalp Hair Regrowth in Adolescents
According to the data in the announcement, at week 36, 42% of patients receiving baricitinib 4 mg once daily and 27% receiving 2 mg achieved SALT ≤20, vs 5% receiving placebo. SALT ≤10 was achieved by 37% and 21% of patients receiving 4 mg and 2 mg, respectively, vs 2% with placebo. Researchers also reported improvements in eyebrow and eyelash coverage among patients with substantial baseline hair loss taking the 4-mg dose. The overall safety profile was consistent with that observed in adults with severe AA.
“The evidence supporting Olumiant’s approval is particularly meaningful because it comes from a Phase 3 study specifically designed for pediatric patients,” said Brittany Craiglow, MD, adjunct associate professor of dermatology at Yale School of Medicine, in the news release.
Source
FDA announcement. September 208, 2026.