MHRA approves deuruxolitinib (Leqselvi) to treat severe alopecia areata in adults – Sun Pharma

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved deuruxolitinib (Leqselvi) from Sun Pharma UK Ltd. to treat severe alopecia areata in adults.  Approval  was based on  two pivotal clinical trials. The trials studied 1223 adult patients with alopecia areata that had lost at least 50% of their hair for more than 6 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 that received Leqselvi scored higher on a scale used to measure scalp hair than those that received the placebo.   Leqselvi was shown to improve hair growth in subjects with severe alopecia areata, with around 30% of subjects experiencing 80% or more scalp hair after 24 weeks of treatment, and around 23% of subjects experiencing 90% or more scalp hair after 24 weeks of treatment.  The most common side effects with deuruxolitinib (which may affect more than 1 in 10 people) are headache and acne.

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. Deuruxolitinib can only be obtained with a prescription. The recommended dose is an 8 mg tablet to be taken twice a day.