Pfizer has secured the European Commission (EC) marketing authorisation for Litfulo (ritlecitinib) to treat severe alopecia areata in adults and adolescents, aged 12 years and above.
Litfulo is a once-daily oral treatment that decreases the activity of certain parts of the immune system that cause hair loss in people with alopecia areata.
Alopecia areata is an autoimmune disease characterised by patchy or complete hair loss on the scalp, face, or body, caused by an underlying immuno-inflammatory pathogenesis.
The drug works by irreversibly and selectively inhibiting Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases.
Pfizer said that its Litfulo is the first medicine authorised by the EC to treat severe alopecia areata in people as young as 12 years of age.
Also, it is also the first and only treatment to selectively inhibit JAK3 and the TEC kinases.
The EC marketing authorisation for Litfulo is valid in all 27 member states of the European Union (EU) along with Iceland, Liechtenstein, and Norway.
The regulatory authorisation follows the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommendation, granted in July this year.
It also follows approvals by the US Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) in June.
Pfizer Global Biopharmaceuticals Business chief commercial officer, president 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.”
The regulatory approval was based on the ALLEGRO clinical trial programme, including the Phase 2b/3 ALLEGRO clinical study which evaluated Litfulo in patients aged 12 years and above.
The Phase 2b/3 study enrolled patients with 50% or more scalp hair loss, including patients with alopecia totalis (total scalp hair loss) and alopecia universalis (total body hair loss).
In the study, treatment with Litfulo 50mg resulted in 90% or more scalp hair coverage in 13.4% of adults and adolescents after 24 weeks, when compared to 1.5% with placebo.
The study also measured Patient Global Impression of Change (PGI-C) response, which was a key secondary outcome supporting the EC approval, said the US drugmaker.
In addition, the EC authorisation is supported by positive data from ALLEGRO-LT, an ongoing open-label, long-term Phase 3 study in adults and adolescents with alopecia areata.
