The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Leqselvi (deuruxolitinib), made by Sun Pharma UK, as a treatment for severe alopecia areata in adults.
Alopecia areata is a condition where the body’s own immune system attacks hair follicles, causing inflammation that leads to hair loss on the scalp, face and/or other parts of the body.
The treatment reduces the activity of enzymes called JAK1, JAK2 and TYK2 relative to JAK3 kinases, which are involved in the inflammation of the hair follicles. This then reduces the inflammation, leading to hair regrowth.
Leqselvi, which can only be obtained with a prescription, was evaluated in two clinical trials. The trials involved 1,223 adult patients with alopecia areata who had lost at least 50% of their hair for more than six months.
Participants received either Leqselvi 8mg, deuruxolitinib 12mg or a placebo for 24 weeks. after which the patients receiving Leqselvi scored higher on a scale used to measure scalp hair than those who received the placebo.
Around 30% of patients experienced 80% or more scalp hair after 24 weeks of treatment, and around 23% experienced 90% or more scalp hair after 24 weeks of treatment.
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.”