New indication gives adolescents ages 12 and older another FDA-approved treatment option for severe alopecia areata The U.S. Food and Drug Administration (FDA) has expanded the approval of Olumiant® (baricitinib) to include adolescents ages 12 and older with severe alopecia areata (AA), providing another important treatment option for young people living with the disease. Olumiant is an oral Janus kinase (JAK) inhibitor taken once daily. The FDA originally approved Olumiant for adults with severe alopecia areata in June 2022, making it the first systemic treatment specifically approved for alopecia areata in the United States. The expanded indication is especially meaningful for adolescents and their families, who historically have had far fewer FDA-approved treatment options than adults. Litfulo® (ritlecitinib), approved in 2023 for people ages 12 and older with severe alopecia areata, was the first FDA-approved treatment available to adolescents with the disease. “For young people living with severe alopecia areata and their families, having a second FDA-approved treatment option represents meaningful progress,” said Ryan Reczek, President & CEO of the National Alopecia Areata Foundation (NAAF). “Alopecia areata can have a profound psychosocial impact on adolescents living with this disease. Expanding the number of evidence-based treatment choices gives them and their families hope and healthcare providers more opportunity to find an approach that is right for each patient.” Alopecia areata is a chronic autoimmune disease in which the immune system mistakenly attacks hair follicles, resulting in partial or complete hair loss on the scalp and body. It can affect people of any age, including children and adolescents. The expanded FDA approval of Olumiant was supported by research specifically evaluating baricitinib in adolescents (12 – 18) with severe alopecia areata. Researchers shared 36-week data from the Phase 3 BRAVE-AA-PEDS trial demonstrating treatment arms from both 2 mg and 4 mg daily doses of Olumiant achieved significant (80%) scalp hair regrowth (27% and 42%, respectively). A smaller but significant group achieved 90% scalp regrowth (37% and 21%) during the same time frame. Those on the 4 mg dosing also achieved significant eyelash and eyebrow regrowth. The approval marks another step in the rapid evolution of alopecia areata treatment. Until 2022, there were no FDA-approved systemic treatments specifically for alopecia areata. Today, multiple FDA-approved therapies are available, and research continues into additional treatments and younger patient populations. NAAF will continue to update the alopecia areata community about new research, treatments, and resources. Read the full press release from Lilly. Learn more about FDA-approved treatments for alopecia areata. Learn more about Olumiant. Find an alopecia areata specialist.
