The European Commission Approves Severe Alopecia Areata Treatment

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On Sept. 19, 2023, Pfizer announced that the European Commission (EC) granted marketing authorization for LITFULO (ritlecitinib) as a treatment for patients 12 years and older with severe alopecia areata. LITFULO is a daily oral capsule, and according to Pfizer it is the first medicine authorized by the EC to treat patients as young as 12 with severe alopecia areata. Pfizer also stated that LITFULO is “the first and only treatment to selectively inhibit Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases.”

The marketing authorization extends to all EU member states, as well as Liechtenstein, Iceland, and Norway. It follows approvals by FDA and the Japanese Ministry of Health, Labor and Welfare in June 2023. The EC approval was based on results from Pfizer’s ALLEGRO clinical trial program, which studied LITFULO in individuals 12 years and older with alopecia areata with 50% or more hair loss on the scalp. The study included those with total hair loss (alopecia totalis) and total body hair loss (alopecia universalis). The study reported that at 24 weeks of treatment, 13.4% patients receiving treatment with LITFULO 50 mg saw 90% or more scalp hair coverage as compared to 1.5% with placebo. Almost half of participants (49.2% ) receiving LITFULO reported “moderate” to “great” improvement in their alopecia areata as compared to 9.2% with placebo.

As of the publishing date of this article, Pfizer is conducting an open-label, long-term Phase III study, ALLEGRO-LT. This study is collecting data for adults with alopecia areata with 25% or greater scalp hair loss and adolescents with alopecia areata with 50% or greater scalp hair loss. Data from this study was included in the submission for approval to the EC.

Source: Pfizer