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# FDA Approves Pfizer Alopecia NDA
- URL: https://www.fdaweb.com/fda-approves-pfizer-alopecia-nda/
- Published: 2023-06-26T12:00:00.000Z
- Updated: 2026-09-14T18:41:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154764

FDA has approved a Pfizer NDA for Litfulo (ritlecitinib), a once-daily oral treatment for individuals 12 years of age and older with severe alopecia areata. The kinase inhibitor is designed to inhibit Janus kinase 3 and the tyrosine kinase expressed in hepatocellular carcinoma family of kinases.

Approval was based on data from the ALLEGRO Phase 2b/3 trial, which enrolled 718 patients with 50% or more scalp hair loss. “In this pivotal study, 23% of patients treated with Litfulo 50 mg had 80% or more scalp hair coverage after six months compared to 1.6% with placebo,” Pfizer says. On the safety side, it says the most common adverse events reported in at least 4% of patients included headache (10.8%), diarrhea (10%), acne (6.2%), rash (5.4%), and urticaria (4.6%).