The US FDA has just given the green light to ritlecitinib, the first and only treatment for severe alopecia in adults and adolescents.
the United States Food and Drug Administration (FDA) has just approved Litfulo™ (ritlecitinib), a once-daily oral treatment, for adolescents 12 years and older and adults with severe alopecia.
Alopecia areata is an autoimmune disease that develops when the immune system attacks hair follicles in the body, causing hair, eyebrows, eyelashes, or facial hair to fall out. The US-approved drug “is a significant advance in the treatment of alopecia areata, an autoimmune disease that previously had no options for adolescents and limited options available for adults,” said Angela Hwang. , president of the Global biopharmaceuticals business at Pfizer.
A clinical trial conducted with more than 700 patients
The FDA has given the green light following a Phase 2/3 clinical trial involving 718 patients with hair loss of 50% or greater, as measured by the Severity of Alopecia Tool (SALT). This trial measured the efficacy and safety of Litfulo at 118 sites in 18 countries.
The results, published last April in The Lancet, indicate that 23% of patients treated with ritlecitinib had hair coverage of 80% or more (SALT≤20) after six months, compared to 1.6% with placebo. The drug’s efficacy and safety were the same between adolescents (12 to 17 years old) and adults (18 years and older).
FDA Approves Pfizer’s LITFULO™ (Ritlecitinib) for Adults and Adolescents With Severe Alopecia AreataPfizer press release, June 2023
Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicenter, phase 2b-3 trialThe Lancet, April 2023