Pfizer gets LITFULO FDA approval for severe alopecia areata

Pfizer has announced that the US Food and Drug Administration (FDA) has granted approval to LITFULO (ritlecitinib) as a once-daily oral treatment for individuals aged 12 and older with severe alopecia areata.

LITFULO is the first and only FDA-approved therapy for adolescents (12+) with severe alopecia areata. The recommended dose for LITFULO is 50 mg.

LITFULO is a kinase inhibitor that targets Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases. Its FDA approval was based on the positive results of the ALLEGRO Phase 2b/3 trial, which enrolled 718 patients with 50% or more scalp hair loss due to alopecia areata across 118 sites in 18 countries.

In the pivotal study, 23% of patients treated with LITFULO 50 mg achieved 80% or more scalp hair coverage (SALT≤20) after six months, compared to 1.6% with placebo. The efficacy and safety of LITFULO were consistent between adolescents and adults. The most commonly reported adverse events (AEs) in at least 4% of patients receiving LITFULO included headache, diarrhea, acne, rash, and urticaria.

Pfizer‘s LITFULO receives FDA approval as first treatment for severe alopecia areata in adolescents and adults. Photo courtesy of Norbert Nagel, Mörfelden-Walldorf, Germany/Wikimedia Commons.

Alopecia areata is an autoimmune disease characterized by patchy or complete hair loss on the scalp, face, or body. LITFULO works by inhibiting JAK3 and TEC family kinases, which are involved in the signaling of cytokines and cytolytic activity of T cells implicated in the pathogenesis of alopecia areata.

Angela Hwang — Pfizer Chief Commercial Officer and President of Global Biopharmaceuticals Business said: “LITFULO is an important treatment advancement for alopecia areata, an autoimmune disease that previously had no FDA-approved options for adolescents and limited options available for adults.

“With today’s approval, adolescents and adults who struggle with substantial hair loss have an opportunity to achieve significant scalp hair regrowth.”

LITFULO will be made available in the coming weeks, providing a significant advancement in the treatment options for individuals with severe alopecia areata. Regulatory applications for LITFULO have also been submitted to various countries worldwide for review, including China, the European Union, Japan, and the United Kingdom.

The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for ritlecitinib, with a decision expected in the third quarter of 2023.

Apart from alopecia areata, LITFULO is currently being evaluated for its potential in treating vitiligo, Crohn’s disease, and ulcerative colitis. Its approval marks a significant milestone in addressing the unmet needs of patients with severe alopecia areata, offering hope for improved hair regrowth and quality of life.