On June 13, Pfizer announced that the U.S. Food and Drug Administration (FDA) approved ritlecitinib (Litfulo), for patients with severe alopecia areata who are aged 12 years and older. Ritlecitinib is an inhibitor of Janus kinase 3 (JAK3) and the TEC family kinases. Approval was based on data from phase IIb/III ALLEGRO trial, results of which were published by King et al in The Lancet. The trial included 718 patients with 50% or more scalp hair loss as measured by the Severity of Alopecia Tool (SALT) enrolled at 118 sites in 18 countries. Experts found that 23% of patients treated with ritlecitnib at the approved recommended dose of 50 mg had 80% more scalp coverage (SALT £ 20) after 6 months of treatment compared to 1.6% of patients who received placebo. According to the investigators, the efficacy and safety of ritlecitinib were consistent among adolescents 12 to 17 years of age and adults aged 18 years and older. The most commonly reported adverse events among patients receiving ritlectinib included headache (in 10.8% of patients), diarrhea (10%), acne (6.2%), rash (5.4%), and urticaria (4.6%). The full prescribing information for ritlectinib can be viewed at labeling.pfizer.com.
August 15, 2023