FDA Approves Pfizer’s Alopecia Drug

The FDA has approved Pfizer’s Litfulo (ritlecitinib), a once-daily oral treatment, for people 12 years of age and older with severe alopecia areata. Alopecia areata is an autoimmune disease characterized by patchy or complete hair loss on the scalp, face, or body. It develops when the immune system attacks the body’s hair follicles, causing hair to fall out. It impacts almost 7 million in the United States, and 20% of them are diagnosed before the age of 18.

Litfulo is a kinase inhibitor, which inhibits Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases. Litfulo will be available in the next few weeks, Pfizer executives said in a press release.

The annual list price of Litfulo is $49,000, which is in line with other specialty dermatologic treatments, according to a Pfizer spokesperson. The company offers assistance through the Pfizer Dermatology Patient Access Program, and eligible patients will be able to get support with access to Litfulo, the spokesperson said.

“While patients may start to develop symptoms of alopecia areata at any age, most people start showing signs in their teens, twenties, or thirties,” Brittany Craiglow, M.D., associate professor Adjunct – Dermatology at Yale School of Medicine, said in a press release.

The approval was based on the pivotal phase 2b/3 ALLEGRO study, which enrolled 718 patients with 50% or more scalp hair loss. In the study, Litfulo met the primary endpoint for improving scalp hair regrowth, with 23% of patients taking the 50 mg dose having 80% or more scalp coverage after six months. The efficacy and safety 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% of patients include headache, diarrhea, acne, rash, and urticaria. Full results from the study were published in The Lancet in April 2023.

Litfulo, which had been granted breakthrough therapy designation from the FDA for alopecia areata, is is also being evaluated to treat patients with vitiligo, Crohn’s disease, and ulcerative colitis.