The once-daily oral medication is the first and only treatment approved by the agency for adolescents with the disease.
On June 23, the FDA approved the use of ritlecitinib (Litfulo), a once-daily oral treatment for alopecia areata for children and adults aged 12 years and older.1 This is the first and only treatment approved by the FDA for adolescents with this disease.
According to Brittany Craiglow, MD, associate professor adjunct, Dermatology, Yale School of Medicine, "Patients may start to develop symptoms of alopecia areata at any age, but most start showing signs in tehir teens, 20s, and 30s," she noted. "Litfulo is a particularly important treatment option for younger patients with substantial hair loss."
Ritlecitinib is a kinase inhibitor, which inhibits JAK3 and the tyrosine kinase expressed in the hepatocellular carcinoma family of kinases.
Alopecia areata is an autoimmune disease affecting 1 in every 1000 children and adolescents. Before this approval, there had been no FDA-approved options for children, and very few options for adults.
The ALLEGRO phase 2b/3 clinical trial enrolled 718 patients with 50% or more scalp hair loss as measured by the Severirty of Alopecia Tool, evaluated the safety and efficacy of Litfulo, 50 mg, in 118 sites in 18 countries. In their findings, 23% of patients treated with Litfulo had 80% or more scalp hair coverage after 6 months, compared with 1.6% with the placebo group. The efficacy and safety of the drug were consistent between adolescents and adults. The most common adverse events reported were headache, diarrhea, acne, rash, and articaria.