Lilly’s Olumiant Shows Strong Hair Regrowth in Adolescents with Severe Alopecia Areata, Backed by CHMP for EU Approval

Eli Lilly and Company and Incyte have announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an expanded use of Olumiant (baricitinib) for adolescents aged 12 to under 18 with severe alopecia areata (AA).

If confirmed by the European Commission in the coming months, this would mark the first JAK inhibitor in the EU specifically approved for adolescents with severe AA, extending the drug’s current indication in adults.

Anabela Cardoso, SVP, Lilly Immunology Medical Affairs said the positive CHMP opinion highlights Olumiant’s potential as a new, evidence‑based treatment option for adolescents with severe alopecia areata, underscoring Lilly’s commitment to addressing the significant unmet need in chronic skin diseases.

Efficacy in Adolescents from BRAVE‑AA‑PEDS

The CHMP opinion is based on 36‑week data from the Phase 3 BRAVE‑AA‑PEDS trial (NCT05723198), the first and largest study specifically designed for children and adolescents with severe AA, defined as ≥50% scalp hair loss (SALT score ≥50) over at least six months but no more than eight years.

In the adolescent cohort (12 to <18 years, ≥30 kg), once‑daily oral Olumiant 2 mg and 4 mg significantly improved scalp, eyebrow, and eyelash hair regrowth versus placebo:

At 36 weeks, treatment with Olumiant showed substantial improvements in hair regrowth compared with placebo. For successful (≥80%) scalp hair coverage, 42.4% of adolescents receiving Olumiant 4 mg achieved this outcome, versus 27.4% on 2 mg and 4.5% on placebo. In terms of near‑complete (≥90%) scalp hair coverage, 36.5% of patients on 4 mg reached this threshold, compared with 21.4% on 2 mg and 2.3% on placebo.

Significant eyebrow regrowth was observed in 50.0% of patients on 4 mg and 24.1% on 2 mg, while no patients on placebo showed meaningful eyebrow regrowth (0%). Eyelash regrowth occurred in 42.9% of those on 4 mg, 25.5% on 2 mg, and 14.0% on placebo, highlighting a clear dose‑dependent benefit of Olumiant over placebo across scalp, eyebrow, and eyelash outcomes.

One‑year data from BRAVE‑AA‑PEDS presented at the 2025 Fall Clinical Dermatology Conference show sustained scalp, eyebrow, and eyelash regrowth in adolescents, reinforcing the durability of the response.

 Safety Profile in Adolescents

The safety profile of Olumiant in adolescents with AA was consistent with that previously observed in pediatric trials of baricitinib in juvenile idiopathic arthritis and moderate‑to‑severe atopic dermatitis. No new safety signals were identified in the adolescent cohort, though the overall safety picture of JAK inhibitors remains closely monitored, especially in younger populations.

The U.S. FDA‑approved labeling for Olumiant includes a Boxed Warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis, primarily based on data in adults; clinicians should review the full prescribing information for detailed risk assessments and monitoring recommendations.

Thierry Passeron, Professor and chair, Department of Dermatology Université Côte d’Azur said If approved in the EU, Olumiant would offer an important therapeutic advance for adolescents with severe alopecia areata, a vulnerable group for whom current options are often inadequate and the psychosocial impact of hair loss is profound.

Olumiant’s Broader Indications and Regulatory Status

Olumiant (baricitinib) is a once‑daily oral JAK inhibitor discovered by Incyte and licensed to Lilly. It is already approved in the U.S., Europe, and Japan for adults with severe alopecia areata, as well as in the U.S. and over 75 countries for adults with moderately to severely active rheumatoid arthritis, and in more than 40 countries for children and adolescents as young as two with moderate‑to‑severe atopic dermatitis. Baricitinib is also authorized in several countries for hospitalized patients with COVID‑19.

Lilly has filed a U.S. application to extend Olumiant’s severe AA indication to adolescents, with a decision expected in the second half of 2026.

Alopecia areata

Alopecia areata is a chronic, T‑cell–mediated autoimmune disorder in which the immune system attacks hair follicles, leading to patchy or diffuse hair loss that can progress to near‑total or complete scalp baldness (alopecia totalis/universalis). In adolescents, early‑onset disease often carries a higher burden of psychological distress, social stigma, and school‑related difficulties, underscoring the need for effective, evidence‑based therapies.

Reference

Lilly’s Olumiant (baricitinib) recommended by CHMP for approval of expanded use in the European Union for adolescents with severe alopecia areata, 27 February 2026, Lilly’s Olumiant (baricitinib) recommended by CHMP for approval of expanded use in the European Union for adolescents with severe alopecia areata | Eli Lilly and Company

European Medicines Agency (EMA) – CHMP Opinion on Olumiant Variation https://www.ema.europa.eu/en/medicines/human/variation/olumiant-0

A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age with Alopecia Areata (BRAVE-AA-PEDS), ClinicalTrials.gov ID NCT05723198, https://clinicaltrials.gov/study/NCT05723198

 Alopecia Areata in Children, National Alopecia Areata Foundation, https://www.naaf.org/alopecia-areata-in-children/