The MHRA has approved deuruxolitinib, marketed as Leqselvi, for the treatment of severe alopecia areata in adults, offering a new therapeutic option for people living with the autoimmune condition.
Alopecia areata occurs when the immune system attacks hair follicles, triggering inflammation that leads to hair loss on the scalp, face or other parts of the body.
Deuruxolitinib works by reducing the activity of JAK1, JAK2 and TYK2 relative to JAK3 kinases, enzymes involved in the inflammatory process at the hair follicle. By dampening this inflammation, the medicine can support hair regrowth.
Julian Beach, MHRA Executive Director, Healthcare Quality and Access, said: “This approval gives adults with alopecia areata another potential treatment option to help manage their condition. As with any medicine, the MHRA will keep the safety and effectiveness of deuruxolitinib under close review.”
Leqselvi is available only on prescription. The recommended dose is an 8 mg tablet taken twice daily.
The approval is based on two pivotal clinical trials involving 1223 adults who had lost at least 50 percent of their hair for more than six months. Participants received either Leqselvi 8 mg, deuruxolitinib 12 mg or a placebo twice daily for 24 weeks.
Those treated with Leqselvi achieved higher scores on a standard measure of scalp hair coverage compared with placebo.
After 24 weeks, around 30 percent of subjects experienced 80 percent or more scalp hair, while around 23 percent achieved 90 percent or more. The results indicate that deuruxolitinib can significantly improve hair growth in people with severe alopecia areata.
