The FDA has approved an expanded indication for Eli Lilly's once-daily oral drug baricitinib (Olumiant) to treat adolescents aged 12 and older with severe alopecia areata. Supported by the BRAVE-AA-PEDS phase 3 trial, the approval introduces a second JAK inhibitor option for teenagers, who face severe hair loss and heightened rates of anxiety and depression. While clinical data show more than half of patients achieved significant hair regrowth at one year, the drug carries a boxed warning for serious infections and cardiovascular risks.
FDA approvals of baricitinib
- ▪On September 25, 2026, Eli Lilly announced the FDA approved an expanded indication for baricitinib, a once-daily oral JAK inhibitor, to treat adolescents aged 12 and older with severe alopecia areata.
- ▪The FDA had previously approved baricitinib to treat adults with severe alopecia areata.
Efficacy outcomes from the BRAVE-AA-PEDS trial
- ▪At 52 weeks in the BRAVE-AA-PEDS trial, 54.1% of adolescents on 4 mg baricitinib achieved a SALT score of 20 or lower, and 41.2% achieved a score of 10 or lower.
- ▪In the BRAVE-AA-PEDS phase 3 trial, 42% of adolescents on 4 mg baricitinib and 27% on 2 mg baricitinib achieved a SALT score of 20 or lower at week 36, compared to 5% on placebo.
BRAVE-AA-PEDS trial details
- ▪The BRAVE-AA-PEDS trial is ongoing with a second cohort of 166 adolescents randomized 1:1 to receive either 4 mg or 2 mg of baricitinib to gather more safety data.
- ▪The BRAVE-AA-PEDS trial randomized 257 adolescents with a median Severity of Alopecia Tool score of 100, representing complete scalp hair loss.
Safety profile and warnings of baricitinib
- ▪The overall safety profile of baricitinib in the pediatric cohort of the BRAVE-AA-PEDS trial was consistent with the safety profile observed in adult cohorts during earlier studies.
- ▪Baricitinib carries a boxed warning citing risks for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Previous approval and trial results of ritlecitinib
- ▪Baricitinib is the second systemic oral JAK inhibitor approved for adolescents aged 12 and older with severe alopecia areata, following the June 2023 approval of ritlecitinib.
- ▪In the ALLEGRO trial supporting its approval, 23% of patients on 50 mg of ritlecitinib reached a SALT score of 20 or lower after 6 months, compared to 1.6% on placebo.
Prevalence and psychological impact of alopecia areata
- ▪Alopecia areata in pediatric patients is associated with increased rates of anxiety and depression, representing a significant psychiatric burden during adolescence.
- ▪Up to 2% of people develop alopecia areata in their lifetimes, and nearly 40% of cases begin before age 20, with earlier onset often linked to more extensive hair loss.
Debatable claims
- ▪The benefits of baricitinib for adolescent alopecia outweigh its boxed warning risks
- ▪Clinicians should initiate systemic JAK inhibitors for adolescent alopecia before complete hair loss occurs
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