LONDON, March 12 -- The government of the United Kingdom issued the following news:

The Medicines and Healthcare products Regulatory Agency (MHRA) hasapproveddeuruxolitinib(Leqselvi)totreat 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.

Deuruxolitinibworks 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, MHRA Executive Director, Healthcare Quality and Access, said:

Thisapproval givesadults with alopecia areataanotherpotentialtreatmentoptionto helpmanage their condition.

As with any medicine, the MHRA will keep the safety and effectiveness ofdeuruxolitinibunder close review.

Deuruxolitinibcan only be obtained with a prescription. The recommended dose isan8mgtabletto be taken twice a day.

This medicine was evaluated in two pivotal clinical trials. The trials studied1223adult patients with alopecia areata that had lost at least 50% of their hair for more than 6 months. Inbothtrials, subjects receivedtwice dailyeitherLeqselvi8 mg,deuruxolitinib12 mgor a placebo for 24 weeks.

After 24 weeks, the patients that receivedLeqselviscored higher on a scale used to measure scalp hair than those that receivedtheplacebo.

Leqselviwas shown to improve hair growth in subjects with severealopecia 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 withdeuruxolitinib(which may affect more than 1 in 10 people) are headache and acne.Anyone who suspects they are having a side effect from this medicineisencouraged to talk to their doctor, pharmacist or nurse and report it to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.  

Notes to editors 

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Deuruxolitinibwas approvedon10March2026 toSun Pharma UK Limited.

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This medicine wasapproved via theInternational Recognition Procedure(IRP). 

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This medicine is subject toadditionalmonitoring toallow quick identification of new safety information.More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.   

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The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.  All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.   

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The MHRA is an executive agency of the Department of Health and Social Care.   

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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.

Disclaimer: Curated by HT Syndication.