Pfizer’s Litfulo (ritlecitinib) has been approved by the European Commission (EC) to treat adults and adolescents with severe alopecia areata.
The decision makes Litfulo the first medicine authorised by the EC for use in patients aged as young as 12 years with severe forms of the autoimmune disease.
Affecting approximately 147 million people globally, alopecia areata is characterised by patchy or complete hair loss on the scalp, face, or body.
The condition can develop at any age and nearly 20% of patients are diagnosed before the age of 18.
Litfulo, which is a one-daily oral kinase inhibitor, works by blocking the activity of signalling molecules and immune cells believed to contribute to the loss of hair in patients with alopecia areata.
The EC’s approval follows a recommendation from the European Medicines Agency’s human medicines committee in July and was supported by positive results from the phase 2b/3 ALLEGRO trial, which evaluated Litfulo in patients aged 12 years and older with 50% or more scalp hair loss, including those with total scalp and body hair loss.
Results showed that 13.4% of adults and adolescents saw 90% or more scalp hair coverage after 24 weeks of treatment with Litfulo 50mg compared to 1.5% in the placebo group.
The drug is also being evaluated in the ongoing phase 3 ALLEGRO-LT study, with safety and efficacy data being collected for adults with 25% or greater scalp hair loss and adolescents aged 12 years and older with 50% or greater scalp hair loss.
Angela Hwang, chief commercial officer and president, global biopharmaceuticals business at Pfizer, said: “[The] 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.”
Litfulo has already been approved in the US and Japan for the same patient population.
The drug is also being evaluated for potential additional indications, including non-segmental vitiligo.