Pfizer has received marketing authorisation from the European Commission (EC) for LITFULO (ritlecitinib) for the treatment of adults and adolescents aged 12 years and above with severe alopecia areata.
LITFULO’s marketing authorisation is accepted in all 27 EU member states, as well as in Norway, Liechtenstein and Iceland.
The once-daily oral capsule is said to be the first and only treatment to selectively prohibit Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases.
Its approval was based on data from the ALLEGRO clinical trial programme, which included the ALLEGRO Phase IIb/III study.
The trial assessed LITFULO for this indication in patients with 50% or more scalp hair loss, including those with alopecia universalis (total body hair loss) and alopecia totalis (total scalp hair loss).
Results demonstrated that following 24 weeks of treatment with LITFULO 50mg, 13.4% of adults and adolescents experienced 90% or more scalp hair coverage, compared with 1.5% with a placebo.
Pfizer Global Biopharmaceuticals Business president and chief commercial officer Angela Hwang said: “Today’s approval of LITFULO in Europe is an important milestone for patients as young as 12 years of age with substantial hair loss from alopecia areata, as they now have an opportunity to achieve significant hair regrowth.
“Previously, there were no treatment options approved by the EC for adolescents with severe alopecia areata, and Pfizer is proud to be bringing forward this new innovative medicine for patients living with the challenges brought by this autoimmune disease.”
Alopecia areata is an autoimmune condition that causes hair loss in patches on the scalp, face, or body.