Pfizer’s Litfulo (ritlecitinib) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat severe alopecia areata in patients aged 12 years and older.

NICE’s decision, which could benefit up to 14,000 people, makes Litfulo the first treatment for severe alopecia areata recommended by the agency for use on the NHS. 

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.

NICE’s decision on the drug follows an approval from the Medicines and Healthcare products Regulatory Agency (MHRA) in November for the same patient population. 

The MHRA’s decision 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.

Helen Knight, director of medicines evaluation at NICE, said: “I’m delighted that we are now able to recommend this innovative treatment, the first time a medicine for severe alopecia areata has been recommended by NICE for use in the NHS.”