Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization to LITFULO? (ritlecitinib) to treat adults and adolescents 12 years and older with severe alopecia areata. LITFULO, a once-daily oral capsule, is the first medicine authorized by the EC to treat individuals as young as 12 years old with severe alopecia areata.
LITFULO is also the first and only treatment to selectively inhibit Janus kinase 3 (JAK3) and tyrosine kinase expressed in the hepatocellular carcinoma (TEC) kinase family. The marketing authorization for LITFULO is valid in all 27 EU Member States, as well as Iceland, Liechtenstein and Norway. This authorization follows the recommendation for approval by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in July 2023.
It also follows approvals from the United States Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labor and Welfare (MHLW) in June 2023. The approval was based on the program of ALLEGRO clinical trials, which included ALLEGRO Phase 2b/3. study (NCT03732807) that studied LITFULO 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). scalp) and alopecia universalis (total hair loss on the body). Results from this pivotal study showed that 13.4% of adults and adolescents experienced scalp hair coverage of 90% or more (SALT = 10) after 24 weeks of treatment with LITFULO 50 mg, compared to 1.5 % with the placebo.
Patient response to global impression of change (PGI-C) was also measured and was a key secondary outcome supporting endorsement. At week 24, 49.2% of participants reported a “moderate” response to ?super?
improvement in their alopecia areata compared to 9.2% with the placebo. ALLEGRO-LT (NCT04006457) is an ongoing, long-term, open-label Phase 3 study, with safety and efficacy data collected in adults with alopecia areata with scalp hair loss of 25% or more and adolescents from 12 years old with alopecia. areata with hair loss of 50% or more from the scalp. Long-term efficacy and safety data from this study were included in the submission to support approval.
The most common adverse reactions reported with LITFULO 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%). LITFULO is a first-of-its-kind treatment that irreversibly and selectively inhibits JAK3 and the TEC family of kinases by blocking ?-common cytokine signaling and reducing the cytolytic activity of NK and CD8+ cells. This decreases the activity of parts of the immune system involved in the inflammation of hair follicles that causes hair loss in people with alopecia areata.
Ritlecitinib is also being evaluated for possible additional indications. The Tranquillo Phase 3 study (NCT05583526) is investigating the efficacy, safety, and tolerability of ritlecitinib in adults and adolescents with non-segmental vitiligo. LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older.
