Pfizer's JAK/TEC inhibitor Litfulo has secured a groundbreaking recommendation for NHS use, becoming the first approved drug therapy for severe alopecia areata in the United Kingdom. The approval marks a significant milestone for approximately 14,000 people affected by this autoimmune condition that causes hair loss across the body.
The cost-effectiveness agency NICE reversed its initial position on Litfulo (ritlecitinib) following additional data submission and an improved pricing structure from Pfizer. The treatment, administered as a once-daily tablet, is now approved for patients aged 12 and older, addressing a significant unmet medical need.
Clinical Efficacy and Trial Results
The recommendation is supported by compelling data from the phase 2b/3 ALLEGRO trial, which enrolled 718 patients with 50% or greater scalp hair loss. The study demonstrated remarkable efficacy, with 23% of Litfulo-treated patients achieving 80% hair coverage, compared to just 1.6% in the placebo group, as measured by the Severity of Alopecia Tool (SALT).
Further reinforcing its therapeutic value, 13.4% of patients reached 90% or more scalp hair coverage after 24 weeks of treatment, versus 1.5% with placebo. Importantly, the treatment benefits showed durability, with improvements maintaining for up to two years.
Disease Impact and Patient Population
Alopecia areata, an autoimmune disorder targeting hair follicles, affects approximately 2% of the population during their lifetime. The condition can impact individuals regardless of age, gender, race, or ethnicity, with peak prevalence occurring between ages 10 and 30. Notably, almost 20% of diagnoses occur before age 18, highlighting the importance of having treatment options available for younger patients.
Treatment Landscape and Market Impact
The approval represents a significant advancement over current treatment options, which primarily rely on corticosteroids. While these immunosuppressive drugs have been the standard of care, their long-term use can lead to serious side effects, limiting their therapeutic utility.
Helen Knight, director of medicines evaluation at NICE, emphasized the significance of this approval: "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."
The rapid approval process, completed just 16 weeks after MHRA licensing, demonstrates NICE's commitment to expediting access to innovative therapies. This development is particularly noteworthy as it follows the recent rejection of Eli Lilly's JAK1/2 inhibitor Olumiant (baricitinib) for the same indication.
Market analysts project that the global alopecia areata treatment market could exceed $1 billion, underscoring the significant commercial potential and unmet medical need this approval addresses.
