FDA Expands Baricitinib Approval to Adolescents With Severe Alopecia Areata

The FDA has extended approval of baricitinib (Olumiant; Eli Lilly) to adolescents aged 12 years and older with severe alopecia areata (AA), marking the first systemic oral therapy cleared for this age group in the US. The decision, announced September 25, 2026, was supported by 36-week data from BRAVE-AA-PEDS, described as the first and largest phase 3 trial designed specifically for pediatric patients with severe AA.¹

"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 a press release. "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."¹

BRAVE-AA-PEDS (NCT05723198) is an ongoing, randomized, placebo-controlled phase 3 trial enrolling patients aged 12 to under 18 years with a Severity of Alopecia Tool (SALT) score ≥50, reflecting at least 50% scalp hair loss, with a current episode duration of at least 6 months but no more than 8 years. The first cohort randomized 257 adolescents 1:1:1 to once-daily placebo, baricitinib 4 mg, or baricitinib 2 mg. A second cohort of 166 adolescents was randomized 1:1 to the two active doses to supplement safety data.^2,3

At baseline, the median SALT score was 100—indicating complete scalp hair loss—and participants had been living with AA for a mean of 6.4 years. The primary endpoint, a SALT score ≤20 (≥80% scalp coverage) at Week 36, was achieved by 42% of patients in the 4-mg group and 27% in the 2-mg group, compared with 5% on placebo. A SALT score ≤10 (≥90% scalp coverage) was achieved by 37% and 21% of patients in the 4-mg and 2-mg groups, respectively, versus 2% on placebo. Improvements in eyebrow and eyelash coverage were also reported among patients treated with the 4-mg dose.^2,3

The overall safety profile in adolescents was consistent with that observed in adults with severe AA. The FDA-approved labeling carries a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis.

Clinical Context. AA is a chronic, immune-mediated condition resulting in unpredictable, often extensive hair loss. Lifetime incidence is estimated at approximately 2.1%, and nearly 40% of cases present before age 20.^4,5 Early-onset disease tends to be more severe and refractory, and the psychosocial consequences during adolescence—a period of heightened identity development—can be considerable. Until this approval, no systemic therapy was FDA-cleared for patients under 18 years with severe AA, leaving clinicians with limited, off-label options.

Drug and Drug-Class Background. Baricitinib is a selective, oral Janus kinase (JAK) 1/2 inhibitor originally discovered by Incyte and licensed to Lilly. It modulates cytokine signaling pathways implicated in the autoimmune attack on hair follicles. The drug received FDA approval in 2022 as the first systemic treatment for severe AA in adults, and has also been approved for adults with moderately to severely active rheumatoid arthritis and for hospitalized adults with COVID-19. In April 2026, the European Commission extended approval to adolescents aged 12 to under 18 years for severe AA.¹

Limitations and Next Steps. The approval is based on a single trial cohort at a fixed 36-week timepoint. Data on pediatric patients younger than 12, durability of response after dose reduction from 4 mg to 2 mg, and long-term safety in adolescents remain under investigation as BRAVE-AA-PEDS continues. The labeled boxed warning, while primarily driven by adult data, applies to this population and warrants careful benefit-risk discussion, particularly given the cardiovascular and malignancy signals associated with the JAK inhibitor class. Prescribers should note that the MACE and thrombosis warnings are most relevant to adults aged 50 and older with cardiovascular risk factors, a profile distinct from most adolescent patients.

References

1. FDA approves Lilly's Olumiant (baricitinib) for pediatric patients 12 years of age and older with severe alopecia areata. News release. Eli Lilly. 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. 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.
3. Craiglow 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.
4. 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
5. Villasante Fricke AC, Miteva M. Epidemiology and burden of alopecia areata: a systematic review. Clin Cosmet Investig Dermatol. 2015;8:397-403. doi:10.2147/CCID.S53985