Pfizer’s Litfulo (ritlecitinib) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat severe alopecia areata in patients aged 12 years and older.

Affecting approximately 147 million people globally, alopecia areata is an autoimmune disease 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 enzymes in the body involved in inflammation at the hair follicle. This reduces the inflammation, leading to hair regrowth in patients with alopecia areata.

The MHRA’s decision on the drug 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.

The UK regulator’s decision comes just over a month after the European Commission approved Litfulo, also for use in adults and adolescents with severe alopecia areata.

The drug has already been approved in the US and Japan for the same patient population and is being evaluated for potential additional indications, including non-segmental vitiligo.

Nicole Friedland, president and chief executive officer of the National Alopecia Areata Foundation, said at the time of the US Food and Drug Administration’s approval: “People living with alopecia areata are often misunderstood, and their experience is frequently trivialised as ‘just hair’. However, it is a serious autoimmune disease that can have considerable negative impact beyond the physical symptoms.

“We believe the approval of Litfulo is a significant advancement for the treatment of alopecia areata, particularly for [teenagers].”

https://www.pmlive.com/pharma_news/pfizers_litfulo_approved_by_mhra_for_adults_and_adolescents_with_alopecia_areata_1503291