Therapy Areas: Inflammatory Diseases
Pfizer's LITFULO gains EC approval for treating severe alopecia areata in adolescents and adults
19 September 2023 -

Biopharmaceutical company Pfizer Inc (NYSE: PFE) announced on Tuesday that it has received European Commission (EC) marketing authorisation for LITFULO (ritlecitinib) to treat severe alopecia areata in adults and adolescents aged 12 and above. LITFULO is the first EC-approved medicine for this condition in individuals as young as 12. It selectively inhibits Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases.

This authorisation applies to all 27 EU member states, Iceland, Liechtenstein and Norway. It follows approvals from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), the U.S. Food and Drug Administration (FDA), and the Japanese Ministry of Health, Labour and Welfare (MHLW) in July and June 2023.

The approval stems from the ALLEGRO clinical trial program, including the ALLEGRO Phase 2b/3 study (NCT03732807) showing significant hair coverage improvement with LITFULO.

Ongoing Phase 3 study ALLEGRO-LT (NCT04006457) collects long-term safety and efficacy data for adults and adolescents with alopecia areata.

Common adverse reactions to LITFULO include diarrhea, acne, upper respiratory tract infections, urticaria, rash, folliculitis, and dizziness.

Alopecia areata, an autoimmune disease, results in hair loss on the scalp, face, or body, impacting about 2% of the population. LITFULO is a unique treatment inhibiting JAK3 and TEC family kinases, reducing inflammation in hair follicles.

Pfizer is also evaluating ritlecitinib for potential use in non-segmental vitiligo (Tranquillo Phase 3 study, NCT05583526).

LITFULO is indicated for severe alopecia areata in adults and adolescents 12 years and older, with limitations on its use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or potent immunosuppressants. Pfizer aims to make a positive impact on patients' lives through innovative healthcare products, including medicines and vaccines, while collaborating with healthcare providers, governments and communities worldwide.