FDA approves Lilly's Olumiant (baricitinib) for pediatric patients 12 years of age and older with severe alopecia areata

FDA approval supported by data from BRAVE-AA-PEDS, the first and largest Phase 3 study specifically designed to evaluate pediatric patients with severe alopecia areata (AA) Treatment with Olumiant resulted in substantial scalp hair regrowth, as well as improvements in eyebrows and eyelashes Severe AA can result in extensive hair loss during adolescence, a formative stage of life INDIANAPOLIS , Sept. 25, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY ) announced today that the U.S. Food and Drug Administration (FDA) approved Olumiant (baricitinib), a once-daily pill, for the treatment of pediatric patients 12 years of age and older with severe alopecia areata (AA). 1 The approval expands Olumiant's U.S. label, building on its established use in adults with moderately to severely active rheumatoid arthritis and severe AA. AA is a chronic immune-mediated disease that causes unpredictable hair loss. As many as 2% of people develop AA at some point in their lives, 2 and nearly 40% of cases occur before the age of 20. 3 Early-onset AA can be more severe and lead to extensive hair loss. 3 "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," 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. Expanding Olumiant to patients as young as 12 provides them a much-needed treatment choice and reinforces our commitment to advancing care for people living with immune-mediated diseases." The FDA approval is based on 36-week data from the adolescent cohort (ages 12 to under 18) of BRAVE-AA-PEDS, the first and largest Phase 3 study specifically designed to evaluate pediatric patients with severe AA. 4 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. 1 At Week 36, treatment with once-daily Olumiant delivered: 1 80% or more scalp hair coverage, as measured by a SALT score ≤ 20, in 42% of patients treated with Olumiant 4 mg and 27% treated with Olumiant 2 mg, compared with 5% receiving placebo. 90% or more scalp hair coverage, as measured by a SALT score ≤ 10, in 37% of patients treated with Olumiant 4 mg and 21% treated with Olumiant 2 mg, compared with 2% receiving placebo. Improved eyebrow and eyelash coverage among patients with substantial eyebrow and eyelash hair loss at baseline treated with Olumiant 4 mg. The overall safety profile observed in pediatric patients 12 years of age and older with severe AA is consistent with the safety profile in adults with severe AA. 1 The U.S. FDA-approved labeling for Olumiant includes a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis. 1 See below for full Safety Summary. "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, M.D., 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." Olumiant is available as 4 mg, 2 mg and 1 mg tablets. 1 The recommended dose is Olumiant 2 mg/day, with an increase to 4 mg/day if treatment response is inadequate. 1 For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4 mg/day. Once an adequate response is achieved on 4 mg/day, the dosage is to be decreased to 2 mg/day. 1 "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." Lilly is committed to ensuring patients have access to much-needed medicines. Today, Olumiant has coverage at three of the largest pharmacy benefit managers (PBMs) for adults with severe AA. 5 Through Lilly Support Services™ for Olumiant, Lilly offers a patient support program including co-pay assistance for eligible, commercially insured patients. Learn more about Olumiant ; view the 2 mg and 4 mg product photos and brand logo . Since 2017, more than 33,000 patients have been prescribed Olumiant in the U.S. 6 Olumiant is a once-daily, oral JAK inhibitor discovered by Incyte and