A new option for teens losing their hair

The FDA has approved an expanded indication for baricitinib (Olumiant, Lilly), a once-daily oral JAK inhibitor, for adolescents aged 12 and older with severe alopecia areata. This makes it the second JAK inhibitor approved for this age group, joining ritlecitinib (Litfulo, Pfizer), which received the green light back in June 2023.

The approval is backed by data from BRAVE-AA-PEDS — the largest phase 3 trial specifically designed for pediatric patients with severe alopecia areata. Teens who started treatment before complete hair loss were the strongest responders. The recommended dose is 2 mg per day, with an option to increase to 4 mg if the response is inadequate. As with other JAK inhibitors, baricitinib carries a boxed warning for serious infections, malignancy, cardiovascular events, and thrombosis.

By the Numbers

• More than 50% of adolescents treated with baricitinib achieved complete or near-complete scalp hair regrowth at 1 year
• Approved for patients as young as age 12 for alopecia areata
• Available in 1 mg, 2 mg, and 4 mg tablet strengths
• Already approved in 40+ countries for other indications in children as young as age 2

Why it matters: Severe alopecia areata can be especially devastating for adolescents, with early-onset cases often being more extensive. Having a second approved JAK inhibitor gives clinicians more flexibility — patients who don't respond to one drug now have another evidence-backed option to try.