FDA Approves Lilly's Olumiant for Adolescents 12 and Older With Severe Alopecia Areata
核心洞察
The FDA approved Eli Lilly's once-daily oral JAK inhibitor Olumiant (baricitinib) for pediatric patients 12 years and older with severe alopecia areata (搜索), expanding its existing US label.
The decision rests on 36-week data from BRAVE-AA-PEDS, the first and largest Phase 3 trial designed specifically for pediatric severe alopecia areata (搜索).
At Week 36, 42% of patients on Olumiant 4 mg and 27% on 2 mg achieved at least 80% scalp hair coverage versus 5% on placebo.
Eli Lilly and Company received US Food and Drug Administration (搜索) approval for Olumiant (baricitinib) in pediatric patients 12 years of age and older with severe alopecia areata (搜索) (AA), expanding the drug's US label beyond its existing adult indications. Olumiant is a once-daily oral JAK inhibitor discovered by Incyte and licensed to Lilly.
The approval covers adolescents with severe AA, a chronic immune-mediated disease that causes unpredictable hair loss. As many as 2% of people develop AA at some point in their lives, and nearly 40% of cases occur before the age of 20. Early-onset AA can be more severe and lead to extensive hair loss.
"Today's approval marks an important milestone for young people living with severe alopecia areata (搜索) and their families, who have had limited treatment options to date," said Adrienne Brown, executive vice president and president, Lilly Immunology. "The visible and often extensive hair loss that comes with severe alopecia areata can have a profound impact on anyone, especially adolescents who are at a pivotal stage of life."
BRAVE-AA-PEDS Efficacy at Week 36
The FDA decision is based on 36-week data from the adolescent cohort, ages 12 to under 18, of BRAVE-AA-PEDS (NCT05723198), described by Lilly as the first and largest Phase 3 study specifically designed to evaluate pediatric patients with severe AA. At baseline, the median Severity of Alopecia Tool (SALT) score was 100, indicating complete scalp hair loss, and patients had been living with AA for a mean of 6.4 years.
At Week 36, 80% or more scalp hair coverage, measured as a SALT score of 20 or lower, was achieved by 42% of patients treated with Olumiant 4 mg and 27% treated with Olumiant 2 mg, compared with 5% of those receiving placebo. Coverage of 90% or more, measured as a SALT score of 10 or lower, was reached by 37% of patients on Olumiant 4 mg and 21% on Olumiant 2 mg, compared with 2% on placebo. Patients with substantial eyebrow and eyelash hair loss at baseline also showed improved eyebrow and eyelash coverage on Olumiant 4 mg.
The trial enrolled adolescents weighing at least 30 kg with a SALT score of 50 or higher, meaning at least 50% scalp hair loss, and a current episode of severe AA lasting at least six months but no more than eight years. The first cohort of 257 adolescents was randomized 1:1:1 to once-daily placebo, Olumiant 4 mg or Olumiant 2 mg, with a SALT score of 20 or lower at Week 36 as the primary endpoint. A second cohort of 166 adolescents was randomized 1:1 to Olumiant 4 mg or Olumiant 2 mg to accumulate further safety data.
"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," said Brittany Craiglow, M.D., adjunct associate professor of dermatology, Yale School of Medicine.
Safety and Dosing
The overall safety profile observed in pediatric patients 12 years of age and older with severe AA is consistent with the profile in adults with severe AA. The FDA-approved labeling for Olumiant includes a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis. Common side effects in patients treated for alopecia areata include upper respiratory tract infections, headache, acne, increased cholesterol levels, increased muscle enzyme levels, urinary tract infection, increased liver enzyme levels, folliculitis, tiredness, lower respiratory tract infections, nausea, genital yeast infection, anemia, neutropenia, abdominal pain, shingles and increased weight.
Olumiant is available as 4 mg, 2 mg and 1 mg tablets. The recommended dose is 2 mg per day, increased to 4 mg per day if treatment response is inadequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, Lilly advises considering treatment with 4 mg per day; once an adequate response is achieved on 4 mg, the dosage is decreased to 2 mg per day. It is not known whether Olumiant is safe and effective in children with juvenile idiopathic arthritis or with severe alopecia areata (搜索) who are younger than 12 years old.
Regulatory and Access History
Olumiant was first approved by the FDA in 2022 for adults with severe AA, making it the first systemic treatment approved in the US for the condition. In April 2026, the European Commission approved Olumiant for adolescents ages 12 to under 18 with severe AA. Baricitinib is also approved in the US and more than 75 countries for adults with moderately to severely active rheumatoid arthritis, and in the US for hospitalized adults with COVID-19. Olumiant is now approved for adults and pediatric patients 12 years of age and older with severe AA in the US, European Union and Japan.
Since 2017, more than 33,000 patients have been prescribed Olumiant in the US. Lilly said Olumiant has coverage at three of the largest pharmacy benefit managers for adults with severe AA, and the company offers a patient support program including co-pay assistance for eligible, commercially insured patients through Lilly Support Services.
"Alopecia areata can affect much more than hair, particularly during adolescence, when young people are navigating important personal and social milestones," said George Gondo, chief mission officer, National Alopecia Areata Foundation. "More treatment choices mean more families have the opportunity to find the option that's right for their child, together with their doctor."