European Commission Approves Pfizer’s LITFULO™ for Adolescents and Adults With Severe Alopecia Areata

发布时间： 2023-09-25 阅读：102次

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September 19, 2023 -- Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for LITFULO™ (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata. LITFULO 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.

Alopecia areata is an autoimmune disease characterized by patchy or complete hair loss on the scalp, face, or body. The disease has an underlying immuno-inflammatory pathogenesis and develops when the immune system attacks the body’s hair follicles, causing hair to fall out. Impacting approximately 2% of the population at some point during their lifetime, alopecia areata can affect people of any age, gender, race, or ethnicity and can cause considerable burden beyond hair loss.

The approval was based on the ALLEGRO clinical trial program, which included the ALLEGRO Phase 2b/3 study (NCT03732807) that investigated LITFULO in patients 12 years of age and older with alopecia areata with 50% or more scalp hair loss, including patients with alopecia totalis (total scalp hair loss) and alopecia universalis (total body hair loss). Results from this pivotal study showed that 13.4% of adults and adolescents saw 90% or more scalp hair coverage (SALT ≤10) after 24 weeks of treatment with LITFULO 50 mg compared to 1.5% with placebo. Patient Global Impression of Change (PGI-C) response was also measured and was a key secondary outcome supporting the approval. At week 24, 49.2% of participants reported a response of “moderate” to “great” improvement in their alopecia areata compared to 9.2% with placebo.