European Commission approves ritlecitinib for severe Alopecia areata

The European Commission has authorized the marketing of ritlecitinib for treatment of severe alopecia areata for adolescents and adults .

Ritlecitinib is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3. It is first medicine authorized by the European Commission for treatment of individuals with severe alopecia areata as young as 12 years of age.

“Today’s approval of LITFULO in Europe is an important milestone for patients as young as 12 years of age with substantial hair loss from alopecia areata, as they now have an opportunity to achieve significant hair regrowth,” said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer. “Previously, there were no treatment options approved by the EC for adolescents with severe alopecia areata, and Pfizer is proud to be bringing forward this new innovative medicine for patients living with the challenges brought by this autoimmune disease.”

The marketing authorization for LITFULO is valid in all 27 EU member states, and in Iceland, Liechtenstein, and Norway. This authorization follows the recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in July 2023. It also follows approvals by the U.S. Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labour and Welfare (MHLW) in June 2023.

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.

ALLEGRO-LT (NCT04006457) is an ongoing Phase 3, open-label, long-term study, with safety and efficacy data being collected for adults with alopecia areata with 25% or greater scalp hair loss and adolescents from 12 years of age with alopecia areata with 50% or greater scalp hair loss. Long-term efficacy and safety data from this study were included in the submission to support the 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%).

About Alopecia Areata

Alopecia areata is an autoimmune disease characterized by patchy or complete hair loss on the scalp, face, or body.1,2 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.1,2,3 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.1,2,3,4

About LITFULO™ (Ritlecitinib)

LITFULO is a first-of-its-kind treatment which irreversibly and selectively inhibits JAK3 and the TEC family of kinases by blocking γ-common cytokine signaling and reducing cytolytic activity of NK and CD8+ cells. This decreases the activity of parts of the immune system that are involved in the inflammation of hair follicles that causes hair loss in people with alopecia areata.

Ritlecitinib is also being evaluated for potential 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.