FDA Approves Baricitinib for Adolescents With Severe Alopecia Areata

On September 25, 2026, the US Food and Drug Administration (FDA) approved baricitinib (Olumiant), an oral Janus kinase (JAK) inhibitor for the treatment of adolescents aged 12 years and older with severe alopecia areata (AA). The approval expands the drug's existing indication for adults with severe AA and adults with moderately to severely active rheumatoid arthritis.

The FDA approval is based on 36-week data from BRAVE-AA-PEDS, the first phase 3 trial specifically designed to evaluate adolescents with severe AA. The placebo-controlled study enrolled 257 patients aged 12 to younger than 18 years with at least 50% scalp hair loss (Severity of Alopecia Tool [SALT] score ≥50). At baseline, participants had a median SALT score of 100, indicating complete scalp hair loss, and had lived with AA for a mean of 6.4 years.

At week 36, the study demonstrated:

• 42% of patients receiving baricitinib 4 mg achieved SALT ≤20 (≥80% scalp hair coverage) compared with 5% receiving placebo.
• 27% of patients receiving baricitinib 2 mg achieved SALT ≤20 compared with 5% receiving placebo.
• 37% of patients receiving baricitinib 4 mg achieved SALT ≤10 (≥90% scalp hair coverage) compared with 2% receiving placebo.
• 21% of patients receiving baricitinib 2 mg achieved SALT ≤10 compared with 2% receiving placebo.
• Patients receiving baricitinib 4 mg also demonstrated improvements in eyebrow and eyelash coverage among those with substantial eyebrow and eyelash hair loss at baseline.

“Severe alopecia areata that starts early in life can be more extensive and harder to treat over time, making it important to consider all available treatment options early in the course of disease,” said Brittany Craiglow, MD, adjunct associate professor of dermatology at Yale School of Medicine. “The evidence supporting baricitinib's approval is particularly meaningful because it comes from a phase 3 study specifically designed for pediatric patients, helping clinicians and families make more informed decisions when considering advanced therapies.”

The overall safety profile in adolescents was consistent with that observed in adults with severe AA. The FDA-approved prescribing information for baricitinib includes a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.

Baricitinib is available as 1-mg, 2-mg, and 4-mg tablets. The recommended dose for severe AA is 2 mg once daily, with escalation to 4 mg once daily if treatment response is inadequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyebrow or eyelash involvement, treatment with 4 mg daily may be considered. Once an adequate response is achieved on 4 mg, the dosage should be reduced to 2 mg daily.

Reference

FDA approves Lilly's Olumiant (baricitinib) for pediatric patients 12 years of age and older with severe alopecia areata. News release. Lilly. September 25, 2026. Accessed September 28, 2026. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-olumiant-baricitinib-pediatric-patients-12