FDA Approves Baricitinib for Adolescents With Severe Alopecia Areata

The US Food and Drug Administration (FDA) has approved Eli Lilly and Company's Olumiant (baricitinib) for patients ages 12 and older with severe alopecia areata, the company announced September 25. The approval expands the oral medication's US indication to include adolescents.

Alopecia areata is a chronic immune-mediated disease that causes unpredictable hair loss. Up to 2% of people develop alopecia areata during their lifetime, and nearly 40% of cases begin before age 20. Disease onset during childhood or adolescence can be associated with more extensive hair loss.

Baricitinib Trial Shows Hair Regrowth in Adolescents With Alopecia Areata

The approval was supported by 36-week results from the adolescent group in BRAVE-AA-PEDS, a Phase 3 study evaluating baricitinib in pediatric patients with severe alopecia areata. Participants were ages 12 to 17 years. The median baseline Severity of Alopecia Tool (SALT) score was 100, indicating complete scalp hair loss, and the mean duration of the current episode of severe alopecia areata was 6.4 years.

At week 36, 42% of patients receiving baricitinib 4 mg and 27% receiving 2 mg achieved a SALT score of 20 or less, corresponding to at least 80% scalp hair coverage, compared with 5% of patients receiving placebo. For a SALT score of 10 or less, corresponding to at least 90% scalp hair coverage, the rates were 37% with 4 mg and 21% with 2 mg, compared with 2% with placebo.

Patients receiving baricitinib 4 mg who entered the study with substantial eyebrow and eyelash hair loss also had improvements in those areas.

"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, Yale School of Medicine. "The evidence supporting Olumiant'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."

Baricitinib Safety and Dosing for Adolescent Alopecia Areata

Lilly reported that the safety profile observed in adolescents was consistent with that reported in adults with severe alopecia areata.

Olumiant carries a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis. The prescribing information also includes warnings and precautions related to hypersensitivity, gastrointestinal perforations, laboratory abnormalities, and vaccinations.

For severe alopecia areata, the recommended dose is 2 mg once daily, with an increase to 4 mg once daily if the response is inadequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, treatment with 4 mg once daily may be considered. The dose should be reduced to 2 mg once daily after an adequate response is achieved.

FDA Approval of Baricitinib for Alopecia Areata in Adolescents

Olumiant is a once-daily oral JAK inhibitor discovered by Incyte and licensed to Lilly. In 2022, the FDA approved baricitinib for adults with severe alopecia areata. The drug is also approved in the United States for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to 1 or more tumor necrosis factor blockers and for hospitalized adults with COVID-19 requiring supplemental oxygen or more advanced respiratory support.

The European Commission approved baricitinib for adolescents ages 12 and older with severe alopecia areata in April 2026.

Lilly reported that more than 33,000 patients in the United States had been prescribed Olumiant since 2017. The figure encompasses the drug's US indications and is not specific to alopecia areata.