FDA approves oral JAK inhibitor for severe alopecia

Ritlecitinib (Litfulo) is indicated for the treatment of severe alopecia areata in adults and adolescents ≥12 years of age. Approval was based on the phase 2b/3 ALLEGRO trial involving 718 participants with ≥50% scalp hair loss. At 24 weeks, a significantly greater proportion of those receiving ritlecitinib 50 mg daily (the recommended dose of Litfulo) achieved a Severity of Alopecia Tool (SALT) score response of ≤20% (≤20% scalp hair loss), compared with placebo (23.0% vs. 1.6%).