MHRA approves Leqselvi for severe alopecia areata
The Medicines and Healthcare products Regulatory Agency (MHRA) has officially 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.
Mechanism of Action
The treatment reduces the activity of enzymes called JAK1, JAK2 and TYK2 relative to JAK3 kinases, which are crucially involved in the inflammation of the hair follicles. This then reduces the inflammation, ultimately leading to hair regrowth.
Clinical Trial Evaluation
Leqselvi, which can only be obtained with a prescription, was rigorously 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.
- Around 23% of patients experienced 90% or more scalp hair after 24 weeks of treatment.
“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.”
