FDA Approves Litfulo (ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata
Pfizer Inc. has announced that 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 approved recommended dose for Litfulo is 50 mg. It is the first and only treatment approved by the FDA for adolescents (12+) with severe alopecia areata.
Alopecia areata is an autoimmune disease characterized by patchy or complete hair loss on the scalp, face, or body. It has an underlying immuno-inflammatory pathogenesis and develops when the immune system attacks the body’s hair follicles, causing hair to fall out. This hair loss often occurs on the scalp, but it can also affect eyebrows, eyelashes, facial hair, and other areas of the body. Alopecia totalis (total scalp hair loss) and alopecia universalis (total body hair loss) are types of alopecia areata.
Impacting nearly 7 million people in the U.S. and approximately 147 million people globally, alopecia areata can affect people of any age, gender, race, or ethnicity and can cause considerable burden beyond hair loss. Nearly 20% of people with alopecia areata 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, and it will be available in the coming weeks. The most common adverse events reported in at least 4% of patients include headache, diarrhea, acne, rash, and urticaria.
