Pfizer (NYSE: PFE) has been granted registration authorization by the European Commission (EC) for Litfulo (ritlecitinib), a JAK3/TEC inhibitor, for the treatment of severe alopecia areata in adults and adolescents. This once-daily drug is the first to be approved in the region for this autoimmune disease, including teenage patients. The decision follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
Approval Basis and Clinical Trial Results
The approval was grounded in long-term efficacy and safety data from an ongoing late-stage study, as well as results from a placebo-controlled Phase IIb/III trial. The trial demonstrated that Litfulo significantly increased the rate of patients achieving 90% or more scalp hair coverage from 1.5% to 13.4%, and the rate of participants reporting moderate-to-great improvement increased from 9.2% to 49.2%.
Global Approvals and Market Access
According to Pfizer, Litfulo has already received regulatory approval in Japan and the United States earlier this year, expanding access to this treatment for patients worldwide.-Fineline Info & Tech
