FDA Approves Olumiant for Adolescents With Severe Alopecia Areata

The FDA approved baricitinib (Olumiant), a once daily pill, for pediatric patients 12 years of age and older with severe alopecia areata (AA). The decision expands the US label for a drug already approved for adults with moderately to severely active rheumatoid arthritis and severe AA. Eli Lilly said the approval rests on data from BRAVE-AA-PEDS (NCT05723198), the first and largest phase 3 study designed specifically for pediatric patients with severe AA.¹

"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," Adrienne Brown, executive vice president and president, Lilly Immunology, said in the news release.¹

AA is a chronic immune-mediated disease that causes unpredictable hair loss. As many as 2% of people develop it at some point in their lives, and nearly 40% of cases occur before the age of 20 years, according to references cited by Lilly.¹

Phase 3 Results at 36 Weeks

The approval is based on 36-week data from the adolescent cohort (ages 12 to under 18 years) of BRAVE-AA-PEDS, an ongoing, placebo-controlled trial. The first cohort enrolled 257 adolescents, randomized 1:1:1 to once-daily placebo, baricitinib 4 mg, or baricitinib 2 mg. The primary end point was 80% or more scalp hair coverage, defined as a score of 20 or less on the Severity of Alopecia Tool (SALT), at week 36. A second cohort of 166 adolescents was randomized 1:1 to the 4-mg or 2-mg dose to gather more safety data.¹

At baseline, the median SALT score was 100, indicating complete scalp hair loss, and patients had lived with AA for a mean of 6.4 years. At 36 weeks, 42% of patients treated with baricitinib 4 mg and 27% of those treated with 2 mg reached 80% or more scalp hair coverage compared with 5% of those given placebo. Coverage of 90% or more (a SALT score of 10 or less) was reached by 37% and 21%, respectively, compared with 2% for placebo.¹

Lilly also reported improved eyebrow and eyelash coverage among patients treated with the 4-mg dose who had substantial hair loss in those areas at baseline.¹

Earlier data from the same trial, presented at the American Academy of Dermatology Annual Meeting in March 2025, put significant eyebrow regrowth at 50% with the 4 mg dose and 24.1% with the 2 mg dose, compared with 0% for placebo. Improved eyelash regrowth was seen in 42.9% and 25.5%, respectively, compared with 14% for placebo.²

"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," Brittany Craiglow, MD, adjunct associate professor of dermatology at Yale School of Medicine, said in the release. Craiglow said the evidence is particularly meaningful because it comes from a phase 3 study designed specifically for pediatric patients.¹

One-Year Data and Safety Profile

Lilly separately reported 52-week results from the trial at the 2025 Fall Clinical Dermatology Conference in October 2025. At one year, 54.1% of patients receiving baricitinib 4 mg and 31% receiving 2 mg reached 80% or more scalp hair coverage, and 41.2% and 26.2% reached 90% or more coverage. Among patients with severe disease at baseline (SALT score, 50-94), 71% receiving 4 mg and 58.6% receiving 2 mg reached 80% or more coverage.³

In a post hoc analysis of adolescents diagnosed with severe AA less than 2 years before starting treatment, 80% of those receiving 4 mg and 64.3% receiving 2 mg reached that threshold.³

Lilly said the overall safety profile in pediatric patients 12 years of age and older with severe AA is consistent with the profile in adults with severe AA. The most common treatment-emergent adverse events at 1 year were acne, upper respiratory tract infection, and influenza, and the company reported no deaths, opportunistic infections, major adverse cardiovascular events, or venous thromboembolic events in the trial. The US label includes a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.^1,3

Dosing, Access, and Pharmacy Considerations

Olumiant comes as 4 mg, 2 mg, and 1 mg tablets. The recommended dose is 2 mg/day, increased to 4 mg/day if the response is inadequate, according to the release. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow loss, the release says to consider 4 mg/day, then decrease to 2 mg/day once an adequate response is achieved.¹

The patient safety summary in the release advises that patients be tested for tuberculosis before starting baricitinib and have blood tests before and during treatment. Cholesterol should be checked approximately 12 weeks after starting. The summary also states that people taking baricitinib should not receive live vaccines.¹

The FDA first approved baricitinib for adults with severe AA in 2022, making it the first systemic treatment approved in the US for the condition. Lilly said more than 33,000 patients in the US have been prescribed baricitinib since 2017. The European Commission approved the drug for adolescents (ages 12 to under 18 years) with severe AA in April 2026.¹

REFERENCES

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

2. Gallagher A. Baricitinib shows significant hair regrowth for pediatric patients with alopecia areata. Drug Topics. March 12, 2025. Accessed September 28, 2026. https://www.drugtopics.com/view/baricitinib-shows-significant-hair-regrowth-for-pediatric-patients-with-alopecia-areata

3. Eli Lilly and Company. Lilly's baricitinib delivered near-complete scalp hair regrowth at one year for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS trial. News release. October 24, 2025. Accessed September 28, 2026. https://investor.lilly.com/news-releases/news-release-details/lillys-baricitinib-delivered-near-complete-scalp-hair-regrowth