Another approval for Pfizer's Litfulo for severe alopecia areata

The European Commission (EC) has become the third medicines regulator to grant marketing authorization for Litfulo (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata.

Litfulo, developed by US pharma giant Pfizer (NYSE: PFE), a once-daily oral capsule, is the first medicine authorized by the EC to treat individuals as young as 12 years of age with severe alopecia areata. Litfulo is also the first and only treatment to selectively inhibit Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases, Pfizer noted.

This authorization follows the recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in July 2023. It also follows approvals by the US Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labor and Welfare (MHLW) in June 2023.