Pfizer’s LITFULO for Severe Alopecia Areata Approved by FDA

The U.S. Food and Drug Administration (FDA) has approved LITFULO (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. The 50 mg-approved recommended dose for LITFULO is the first and only treatment approved by FDA for adolescents with severe alopecia areata. LITFULO is a kinase inhibitor that inhibits Janus kinase 3 and the tyrosine kinase expressed in hepatocellular carcinoma family of kinases.

FDA approval was based on results of the ALLEGRO Phase IIb/III trial that enrolled 718 patients with 50 percent or more scalp hair loss as measured by the Severity of Alopecia Tool (SALT) evaluated the efficacy and safety of LITFULO at 118 sites in 18 countries. In the study, 23 percent of patients treated with LITFULO 50 mg had 80 percent or more scalp hair coverage (SALT≤20) after six months compared to 1.6 percent with placebo. The efficacy and safety of LITFULO were consistent between adolescents (12 through 17 years of age) and adults (18 years of age and older). The most common adverse events reported in at least 4 percent of patients with LITFULO include headache (10.8 percent), diarrhea (10 percent), acne (6.2 percent), rash (5.4 percent) and urticaria (4.6 percent).

“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,” said Angela Hwang, chief commercial officer and president of Global Biopharmaceuticals Business at Pfizer. “With today’s approval, adolescents and adults who struggle with substantial hair loss have an opportunity to achieve significant scalp hair regrowth.”