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.
Litfulo is a kinase inhibitor which inhibits Janus kinase 3 (J AK3 ) and the tyrosine kinase expressed in hepatocellular carcinoma ( TEC ) family of kinases.
The FDA approval was based on results of clinical trials in alopecia areata. The ALLEGRO phase 2b/3 trial, which enrolled 718 patients with 50% or more scalp hair loss as measured by the Severity of Alopecia Tool ( SALT ), has evaluated the efficacy and safety of Ritlecitinib at 118 sites in 18 countries.
In this pivotal study, 23% of patients treated with Ritlecitinib 50 mg had 80% or more scalp hair coverage ( SALT less than or equal to 20 ) after six months compared to 1.6% with placebo.
The efficacy and safety of Ritlecitinib 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 with Ritlecitinib include headache ( 10.8% ), diarrhea ( 10% ), acne ( 6.2% ), rash ( 5.4% ), and urticaria ( 4.6% ).
Ritlecitinib is an inhibitor of JAK3 and the TEC family kinases. Inhibition of JAK3 and TEC kinase family members by Ritlecitinib may block signaling of cytokines and cytolytic activity of T cells, which is implicated in the pathogenesis of 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 (t otal 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 18.5. ( Xagena )
Source: FDA, 2023