The oral selective Janus kinase (JAK) inhibitor deuruxolitinib (brand name Leqselvi) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for adults with severe alopecia areata.
Deuruxolitinib, for which the recommended dose is an 8 mg tablet taken twice a day, works by reducing the activity of the enzymes JAK1, JAK2 and TYK2 relative to JAK3 kinases, which are important for relaying signals between immune cells and hair follicles. When their activity is reduced, inflammation and attacks from immune cells on the hair follicle are also reduced, which can allow hair to regrow.
Currently, the only National Institute for Health and Care Excellence (NICE)-approved treatment for adults with severe alopecia areata is ritlecitinib, which primarily reduces the activity of JAK3.
Commenting on the approval of deuruxolitinib, Sue Schilling, chief executive officer of the charity Alopecia UK, said: ‘It is pleasing to see that another alopecia areata treatment has received approval from the MHRA. Each new approval is an important step forward and helps expand the range of options available to people seeking effective treatment.’
Deuruxolitinib efficacy and safety
The MHRA approval of deuruxolitinib was based on the results of two pivotal phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2, which studied 1,223 patients aged 18-65 years with severe alopecia areata who had lost at least 50% of their hair for more than six months.
In both clinical trials, patients received either deuruxolitinib 8mg, deuruxolitinib 12 mg, or a placebo twice daily. The primary endpoint was the percentage of patients achieving a Severity of Alopecia Tool (SALT) score of 20 or less at week 24, after a score of 50 or higher at screening and baseline.
Both doses of deuruxolitinib led to significantly higher proportions of patients achieving a SALT score ≤20 after 24 weeks compared to the placebo (8 mg 29.6%; 12 mg 41.5%; placebo 0.8% in THRIVE-AA1 and 8 mg 33.0%; 12 mg 38.3%; placebo 0.8% in THRIVE-AA2).
Deuruxolitinib was well tolerated and adverse events were mild or moderate and consistent with other oral JAK inhibitors. Headache, acne and increased blood creatine phosphokinase were the most common, occurring in ≥5% of patients in both deuruxolitinib groups in the two studies.
The authors noted that further research is required into the long-term efficacy and safety of deuruxolitinib, as well as the durability of treatment response.
Alopecia UK highlighted that deuruxolitinib still requires approval from the National Institute for Health and Care Excellence (NICE) and that the charity will ‘continue to support NICE technology appraisals and hope it will be a positive decision from them later in the year’.
Indeed, Ms Schilling added: ‘Access to effective treatments should not depend on whether someone can afford private healthcare, and we look forward to the possibility of this option becoming available to everyone who could benefit from it.’
The NICE appraisal for deuruxolitinib is currently in progress with publication due in October 2026.
This article was originally published by our sister publication Hospital Healthcare Europe.
