Pfizer's JAK3 Inhibitor Ritlecitinib (Litfulo) Receives EU Approval for Severe Alopecia Areata in Patients Aged 12 and Older

On September 19, Pfizer announced that the European Commission (EC) had approved its JAK3 inhibitor Ritlecitinib (brand name: Litfulo, Ritlecitinib capsules) for marketing, used to treat severe alopecia areata in adolescents aged 12 years and above and adults.

Ritlecitinib is a once-daily oral specific JAK3/TEC inhibitor that exhibits high selectivity for tyrosine kinase members expressed in the TEC kinase family and Janus kinase 3 (JAK3). It can block signaling molecules and immune cell activity that lead to alopecia areata, thereby inhibiting the immune system from attacking hair follicle cells to achieve the purpose of treating alopecia areata. Compared with first-generation pan-JAK inhibitors, Ritlecitinib has an advantage in reducing toxicity. In June 2023, this product received its first FDA approval for marketing to treat alopecia areata in adolescents aged 12 years and older and adults.

This approval for marketing is based on the randomized, double-blind, placebo-controlled Phase IIb/III ALLEGRO study. The study aims to evaluate the efficacy and safety of Ritlecitinib in treating patients aged 12 years and older with alopecia areata (n=718). Enrolled patients had at least 50% hair loss due to alopecia areata, including those with alopecia totalis (complete loss of hair) and alopecia universalis (complete loss of all body hair), and had experienced episodes of alopecia areata lasting from 6 months to 10 years.

Results showed that after 24 weeks of treatment with 50mg Ritlecitinib daily, 13.4% of patients achieved scalp hair coverage ≥90% (SALT≤10, Note: SALT is a tool for measuring the amount of scalp hair loss, with higher scores indicating more severe hair loss), significantly higher than the placebo group (1.5%), reaching the primary endpoint of the study. Regarding the secondary endpoint of Patient Global Impression of Change (PGI-C), after 24 weeks of treatment, 49.2% of patients experienced "moderate" to "very great" improvement in alopecia areata, compared to 9.2% in the placebo group.

In terms of safety, Ritlecitinib was well-tolerated in both adult and adolescent patients. The most common adverse events were diarrhea (9.2%), acne (6.2%), upper respiratory tract infection (6.2%), urticaria (4.6%), rash (3.8%), folliculitis (3.1%), and dizziness (2.3%).

At the same time, Pfizer is also evaluating the safety and efficacy of Ritlecitinib in adult patients with alopecia areata who have a hair loss rate ≥25% and adolescent patients aged 12 years and above with a hair loss rate ≥50%, in an open-label, long-term Phase III ALLEGRO-LT study.

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