Pfizer’s Litfulo becomes first NHS drug for alopecia areata

Pfizer’s JAK/TEC inhibitor Litfulo has been recommended for NHS use as a treatment for hair loss caused by severe alopecia areata, the first drug therapy for a condition that affects around 14,000 people.

Given as a once-daily tablet, Litfulo (ritlecitinib) has been recommended by cost-effectiveness agency NICE for use in people aged 12 and over. The decision comes a few months after the first drug to be approved in the UK for alopecia – Eli Lilly’s JAK1/2 inhibitor Olumiant (baricitinib) – was turned down.

Olumiant was cleared by the MHRA for severe alopecia in adults in 2022, around a year before the UK regulator backed Litfulo for patients aged 12 and over with the autoimmune disorder, which attacks the hair follicles across the body, including the scalp, eyelashes, and eyebrows.

Lilly’s drug was turned down last October on the grounds that it was unlikely to be cost-effective, a month after NICE’s independent appraisal committee arrived at the same conclusion for Litfulo. Now, NICE says it has changed its position on Pfizer’s drug after “a public consultation and the company providing additional information and an improved discount to its price.”

In the phase 2b/3 ALLEGRO trial, which involved 718 patients with 50% or greater hair loss on the scalp, 23% of those treated with Litfulo reached the objective of 80% hair coverage compared to 1.6% of the placebo group, as measured by the Severity of Alopecia Tool (SALT).

Furthermore, 13.4% of patients saw 90% or more scalp hair coverage after 24 weeks of treatment with Litfulo compared to 1.5% with placebo, and the effects of the drug seem to be durable, with improvements extending for up to two years.

Impacting approximately 2% of the population at some point during their lifetime, alopecia areata can affect people of any age, gender, race, or ethnicity. Prevalence of the disorder peaks between 10 and 30 years of age and almost 20% of people are diagnosed before the age of 18.

“Our committee heard how severe alopecia areata can have a significant impact on people’s health and quality of life. I’m delighted that we are now able to recommend this innovative treatment,” said Helen Knight, director of medicines evaluation at NICE.

“It is especially pleasing that we have been able to recommend ritlecitinib just 16 weeks after it was granted a licence by the [MHRA], demonstrating NICE’s commitment to getting the best care to patients fast,” she added.

Analysts think that alopecia areata could represent a $1 billion-plus market opportunity worldwide, as current treatment relies on corticosteroid drugs, which suppress the immune system, but can have serious side effects if used long-term.

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