The Medicines and Healthcare products Regulatory Agency (MHRA) has approved deuruxolitinib (Leqselvi) to treat severe alopecia areata in adults.

Alopecia areata is a disease 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.

Deuruxolitinib works by reducing the activity of enzymes called JAK1, JAK2 and TYK2 relative to JAK3 kinases, which are involved in inflammation at the hair follicle. This reduces the inflammation, leading to hair regrowth in patients with alopecia areata.

Julian Beach, Executive Director, Healthcare Quality and Access, MHRA, 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. Deuruxolitinib can only be obtained with a prescription. The recommended dose is an 8 mg tablet to be taken twice a day.”

This medicine was evaluated in two pivotal clinical trials. The trials studied 1,223 adult patients with alopecia areata that had lost at least 50 percent of their hair for more than six months. In both trials, subjects received twice daily either Leqselvi 8 mg, deuruxolitinib 12 mg or a placebo for 24 weeks. 

After 24 weeks, the patients who received Leqselvi scored higher on a scale used to measure scalp hair than those who received the placebo.

Leqselvi was shown to improve hair growth in subjects with severe alopecia areata, with around 30 percent of subjects experiencing 80 percent or more scalp hair after 24 weeks of treatment, and around 23 percent of subjects experiencing 90 percent or more scalp hair after 24 weeks of treatment. 

The most common side effects with deuruxolitinib (which may affect more than one in 10 people) are headache and acne.