Litfulo is said to be the first and only treatment approved by the FDA for adolescents with severe alopecia areata, based on results from Phase 2b/3 trial ALLEGRO clinical trial, which evaluated the efficacy and safety of Litfulo in 718 patients
New Pfizer HQ Entrance. (Credit: Pfizer Inc.)
Pfizer has received the US Food and Drug Administration (FDA) approval for Litfulo (ritlecitinib 50mg) to treat severe alopecia areata in people aged 12 years and above.
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 disease has two primary forms, Alopecia totalis, the total scalp hair loss, and alopecia universalis, the total body hair loss.
Litfulo is a kinase inhibitor that targets Janus kinase 3 (JAK3) and the tyrosine kinase, which are expressed in hepatocellular carcinoma (TEC) family of kinases.
The drug works by blocking the signalling of cytokines and cytolytic activity of T cells, which is associated with the pathogenesis of alopecia areata.
Litfulo is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
It is the first and only treatment approved by the FDA for adolescents with severe alopecia areata, and will be commercialised in the coming weeks, said the US drugmaker.
Pfizer global biopharmaceuticals business president, and chief commercial officer Angela Hwang said: “Litfulo is an important treatment advancement for alopecia areata, an autoimmune disease that previously had no FDA-approved options for adolescents and limited options available for adults.
“With today’s approval, adolescents and adults who struggle with substantial hair loss have an opportunity to achieve significant scalp hair regrowth.”
The FDA approval is supported by results from Phase 2b/3 trial ALLEGRO clinical trial, which evaluated the efficacy and safety of Litfulo in 718 patients, at 118 sites in 18 countries.
The study participants who had 50% or more scalp hair loss as measured by the Severity of Alopecia Tool (SALT), were experiencing the disease for the past six months to 10 years.
In the Phase 2b/3 trial, 23% of patients treated using Litfulo 50mg experienced 80% or more scalp hair coverage after six months, when compared to 1.6% with a placebo.
Litfulo showed efficacy and safety that were consistent between adolescents and adults.
Headache, diarrhoea, acne, rash, and urticaria, include the most common adverse events, while cases of serious infection, malignancies, thromboembolic events, and lab abnormalities are also reported.
Pfizer has submitted applications seeking approval of Litfulo to treat alopecia areata, in countries including China, the European Union (EU), Japan, and the UK.
The European Medicines Agency (EMA) accepted the company’s Marketing Authorisation Application (MAA), with a decision anticipated in the third quarter of this year.
The US-based pharmaceutical company is currently evaluating Litfulo for the treatment of vitiligo, Crohn’s disease, and ulcerative colitis.