FDA approves baricitinib for adolescents with severe alopecia areata

According to a new announcement from Eli Lilly and Company, the FDA has approved Olumiant (baricitinib), a once-daily oral Janus kinase (JAK) inhibitor, for patients 12 years and older with severe alopecia areata.¹ The approval expands the label beyond adults and is based on 36-week data from the adolescent cohort of the phase 3 BRAVE-AA-PEDS trial.¹

The FDA approved baricitinib for adults with severe alopecia areata in 2022, making it the first systemic therapy approved in the United States for the condition.¹ The new indication gives pediatricians and pediatric dermatologists an oral systemic option for patients aged 12 to under 18 years.¹ The European Commission approved baricitinib for the same adolescent population in April 2026.¹

BRAVE-AA-PEDS (NCT05723198) is an ongoing, placebo-controlled phase 3 trial, which Lilly describes as the first and largest phase 3 study designed specifically for pediatric patients with severe alopecia areata.¹’³ Eligible adolescents were aged 12 to under 18 years and weighed at least 30 kg.¹ Each had a Severity of Alopecia Tool (SALT) score of 50 or higher and a current episode lasting six months to eight years.¹

The first cohort randomly assigned 257 adolescents 1:1:1 to once-daily baricitinib 4 mg, baricitinib 2 mg, or placebo.¹ At baseline, the median SALT score was 100, reflecting complete scalp hair loss, and patients had lived with the disease for a mean of 6.4 years.¹ The primary end point was the proportion of patients achieving a SALT score of 20 or lower, or at least 80% scalp hair coverage, at week 36.¹

At week 36, 42% of patients receiving baricitinib 4 mg and 27% receiving 2 mg met the primary end point, compared with 5% of patients receiving placebo.¹ A second cohort of 166 adolescents was randomly assigned 1:1 to baricitinib 4 mg or 2 mg to accumulate additional safety data.¹

Eyebrow and eyelash outcomes, safety profile, and dosing of baricitinib in adolescents with severe alopecia areata

Both baricitinib doses also exceeded placebo on the more stringent threshold of a SALT score of 10 or lower, or at least 90% scalp hair coverage.¹ At week 36, 37% of patients receiving 4 mg and 21% receiving 2 mg reached this threshold, compared with 2% receiving placebo.¹ Among patients with substantial eyebrow and eyelash hair loss at baseline, baricitinib 4 mg improved eyebrow and eyelash coverage.¹

According to Lilly, the overall safety profile in adolescents was consistent with the profile observed in adults with severe alopecia areata.¹ Olumiant labeling carries a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.¹^,² The most common adverse events in patients treated for alopecia areata include upper respiratory tract infections, headache, acne, increased cholesterol, increased muscle enzymes, urinary tract infection, increased liver enzymes, and folliculitis.¹^,²

The recommended dose is 2 mg daily, increased to 4 mg daily for inadequate response.¹^,² For patients with nearly complete or complete scalp hair loss, clinicians may consider 4 mg daily, with a reduction to 2 mg once an adequate response is achieved.¹^,² Baricitinib is available as 1 mg, 2 mg, and 4 mg tablets.¹

Brittany Craiglow, MD, adjunct associate professor of dermatology at Yale School of Medicine, said in the announcement the evidence behind the approval is "meaningful because it comes from a phase 3 study specifically designed for pediatric patients."¹ She added the data can help clinicians and families make more informed decisions when weighing advanced therapies.¹

The label carries monitoring requirements relevant to adolescent care. Prescribing information calls for tuberculosis testing before initiation, blood counts and liver tests before and during treatment, and a cholesterol check about 12 weeks after starting therapy.¹^,² Patients receiving baricitinib should not receive live vaccines, so vaccination status is worth reviewing before treatment begins.¹^,²

Baricitinib is available through specialty pharmacies nationwide.¹ Lilly offers co-pay assistance for eligible commercially insured patients through Lilly Support Services.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 25, 2026. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-olumiant-baricitinib-pediatric-patients-12

2. Olumiant. Prescribing information. Lilly USA, LLC; 2026. Accessed September 25, 2026. https://pi.lilly.com/us/olumiant-uspi.pdf

3. Passeron T, et al. Baricitinib provides significant hair regrowth in adolescents with severe alopecia areata: 36-week efficacy and safety results from a phase 3 randomized, controlled trial. Presented at: American Academy of Dermatology Annual Meeting; March 7-11, 2025.