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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)
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Treatment with Olumiant resulted in substantial scalp hair regrowth, as well as improvements in eyebrows and eyelashes
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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 theU.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'sU.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," saidAdrienne Brown, executive vice president and president,LillyImmunology. "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."
TheFDAapproval 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
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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.
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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.
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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 TheU.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," saidBrittany 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," saidGeorge 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."
Lillyis 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 ThroughLillySupport Services™ for Olumiant,Lillyoffers 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 theU.S.6 Olumiant is a once-daily, oral JAK inhibitor discovered by Incyte and licensed toLillyand is available through specialty pharmacies nationwide. In 2022, theFDAapproved Olumiant for adult patients with severe AA, making it the first systemic treatment approved in theU.S. for this condition. InApril 2026, theEuropean Commissionalso approved Olumiant for the treatment of adolescents (ages 12 to under 18) with severe AA.
About BRAVE-AA-PEDS
BRAVE-AA-PEDS (NCT05723198) is an ongoing, placebo-controlled, Phase 3 clinical trial involving pediatric patients ages 12 to under 18 years with severe AA, as measured by a SALT score of ≥50 (i.e., who had ≥50% scalp hair loss) and a current episode of severe AA lasting at least six months but no more than eight years.
The first two cohorts of patients enrolled in BRAVE-AA-PEDS included adolescents (ages 12 to under 18 years, weighing ≥ 30 kg). The first cohort included 257 adolescent participants who were randomized in a 1:1:1 ratio to receive once-daily placebo, Olumiant 4 mg or Olumiant 2 mg. The primary endpoint of this study was a SALT score ≤20 (i.e., 80% or more scalp hair coverage) at Week 36. The second cohort of 166 adolescents was randomized 1:1 to Olumiant 4 mg or Olumiant 2 mg to further accumulate safety data.7
About Olumiant
Olumiant, a once-daily, oral JAK inhibitor, was discovered by Incyte and licensed toLilly. Baricitinib is approved in theU.S. and more than 75 countries as a treatment for adults with moderately to severely active rheumatoid arthritis. Olumiant is also approved for adults and pediatric patients 12 years of age and older with severe AA in the US, European Union andJapan. Olumiant is also approved for the treatment of hospitalized adults with COVID-19 in theU.S.
TheU.S.FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events and Thrombosis. See the full Prescribing Information here.1
InDecember 2009,Lillyand Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of Olumiant and certain follow-on compounds for patients with inflammatory and autoimmune diseases.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics.
References
1 Olumiant. Prescribing Information. Lilly USA, LLC.
2 Mirzoyev SA, Schrum AG, Davis MDP, Torgerson RR. Lifetime incidence risk of alopecia areata estimated at 2.1% by Rochester Epidemiology Project, 1990-2009. J Invest Dermatol. 2014;134(4):1141-1142. doi:10.1038/jid.2013.464
3 Villasante Fricke, A. C., & Miteva, M. (2015). Epidemiology and burden of alopecia areata: a systematic review. Clinical, cosmetic and investigational dermatology, 8, 397–403. https://doi.org/10.2147/CCID.S53985
4 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. American Academy of Dermatology Annual Meeting. March 7-11, 2025.
5 Eli Lilly and Company. (2026, June 9). FDA approves Lilly's EBGLYSS® (lebrikizumab-lbkz) for one maintenance dose every eight weeks in patients with moderate-to-severe atopic dermatitis [Press release]. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglyssr-lebrikizumab-lbkz-one-maintenance
6 Enterprise Longitudinal Access and Adjudication Dataset (ELAAD) - September 2026.
7Craiglow B, Piraccini BM, Ohyama M, et al. Impact of severity and disease course on baricitinib treatment response in adolescents with severe AA: updated data from the BRAVE-AA-PEDS trial. Presented at: Society for Pediatric Dermatology Annual Meeting; July 22-25, 2026; Minneapolis, MN.