European Commission Approves Ritlecitinib for Severe AA

The European Commission has authorized the marketing of ritlecitinib to treat adults and adolescents 12 years of age and older with severe alopecia areata. This makes ritlecitinib the first medicine authorized by the EC to treat individuals with severe alopecia areata as young as 12 years of age.

Taken as a once-daily pill, ritlecitinib is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3. In June of 2023, the drug received FDA approval for the treatment of severe alopecia areata in people ages 12 and older in the United States.

According to a press release from Pfizer, which developed the drug, EC approval was based on the pivotal ALLEGRO clinical trial program, which included the ALLEGRO phase 2b/3 study that evaluated ritlecitinib in patients aged 12 years 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 study showed that 13.4% of adults and adolescents achieved 90% or more scalp hair coverage (Severity of Alopecia Tool score of 10 or less) after 24 weeks of treatment with ritlecitinib 50 mg, compared with 1.5% of those on placebo.

The study also measured Patient Global Impression of Change (PGI-C). At week 24, 49.2% of participants treated with ritlecitinib reported a PGI-C response of “moderate” to “great” improvement in their alopecia areata, compared with 9.2% with placebo.

According to results from an ongoing, long-term phase 3 study of ritlecitinib known as ALLEGRO-LT, the most common adverse reactions reported from use of the drug included diarrhea (9.2%), acne (6.2%), upper respiratory tract infections (6.2%), urticaria (4.6%), rash (3.8%), folliculitis (3.1%), and dizziness (2.3%), the company press release said.

This article originally appeared on MDedge.com, part of the Medscape Professional Network.