Pfizer's Litfulo Scores FDA Approval As First Alopecia Treatment For Adolescents

The FDA approved Pfizer Inc's PFE Litfulo (ritlecitinib), an oral treatment for severe alopecia areata in individuals 12 and older.

Litfulo is the first and only FDA-approved treatment for adolescents (12+) with severe alopecia areata.

Alopecia areata is a disease when the immune system attacks hair follicles and causes hair loss. Hair follicles are the structures in the skin that form hair. 

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 the hepatocellular carcinoma (TEC) family of kinases.

The FDA approval is based on clinical trial results, including the ALLEGRO Phase 2b/3 trial.

In the ALLEGRO trial, 23% of patients treated with Litfulo 50 mg achieved 80% or more scalp hair coverage after six months compared to 1.6% with placebo.

The efficacy and safety of Litfulo were consistent across adolescents and adults.

Common adverse events reported with LITFULO include headache, diarrhea, acne, rash, and urticaria.

Litfulo will be available in the coming weeks.

Price Action: PFE shares are down 2.14% at $37.48 during the premarket session on the last check Monday.