FDA Approves Pfizer's JAK Inhibitor for Adolescents with Alopecia Areata Hair Loss

The FDA has approved Pfizer's ritlecitinib, a JAK3 and TEC family inhibitor, for treating severe alopecia areata in individuals aged 12 and older. This decision is based on the ALLEGRO phase 2b/3 trial, which involved 718 participants with at least 50% scalp hair loss. The trial's primary goal was to achieve a SALT score of 20 or less by week 24. All dosing regimens met this endpoint, with the highest-dose group showing 31% of patients reaching the target SALT score, compared to 2% in the placebo group.