The FDA Approves Litfulo® (Ritlecitinib) for the Treatment of Severe Alopecia Areata in Adolescents and Adults

The FDA has approved Litfulo® (ritlecitinib) as the first oral treatment for severe alopecia areata in patients aged 12 and older, marking it as the only FDA-approved treatment for adolescents with this condition. The approval is based on the ALLEGRO phase 2b/3 clinical trial involving 718 patients across 18 countries, which showed that 23% of patients treated with 50 mg of ritlecitinib achieved 80% or more scalp hair coverage after six months, compared to 1.6% with placebo. Ritlecitinib works by inhibiting JAK3/TEC kinases, potentially reducing the immune response that causes hair follicle inflammation. While effective, it may increase susceptibility to infections. Alopecia areata is an autoimmune disease affecting approximately 147 million people worldwide, characterized by sudden hair loss due to the immune system attacking hair follicles.