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

Today, the Medicines and Healthcare Regulatory Agency (MHRA) have approved a JAK inhibitor medicine deuruxolitinib (Leqselvi) to treat severe alopecia areata in adults.  

This is positive news for people with alopecia areata as it gives an additional treatment option for people with severe forms. MHRA is the regulatory body in the UK that ensures a medicine is safe and effective. However, before any new medication can be approved for use in the UK by the NHS, it needs to be approved by the National Institute for Health and Care Excellence (NICE). It is NICE that determines whether the medication is clinically and cost-effective and should, or should not, be made available on the NHS.  

While the MHRA approval is positive news, we are yet to understand what NICE’s decision will be. The NICE appraisal for deuruxolitinib is currently in progress with publication due in October 2026. Alopecia UK is involved as a stakeholder in this appraisal process, and we hope that deuruxolitinib will be approved by NICE to provide adults with severe alopecia areata a further treatment option.  

Currently, the only NICE-approved treatment for adults with severe alopecia areata is ritlecitinib. You can find out more about this treatment here. 

Alopecia UK's CEO Sue Schilling says: 

"It is pleasing to see that another alopecia areata treatment has received approval from the MHRA. Each new approval is an important step forward and helps expand the range of options available to people seeking effective treatment. We hope Leqselvi will now go on to be successfully assessed by NICE so that, in time, it can become available on the NHS. Access to effective treatments should not depend on whether someone can afford private healthcare, and we look forward to the possibility of this option becoming available to everyone who could benefit from it."

Deuruxolitinib is a JAK inhibitor medication that reduces the activity of JAK1, JAK2 and TYK2 proteins. In comparison, ritlecitinib primarily reduces the activity of JAK3.  

The four JAK proteins (JAK1, JAK2, JAK3 and TYK2) are important for relaying signals between immune cells and hair follicles. When their activity is reduced, inflammation and attacks from immune cells on the hair follicle are also reduced, which can allow hair to regrow.  

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. 

Today’s announcement from MHRA is positive and we hope that it will lead to further treatment choice for people affected by alopecia areata. Alopecia UK will continue to support NICE technology appraisals and hope it will be a positive decision from them later in the year.