RegulatoryOfficial

MHRA approves deuruxolitinib (Leqselvi) for severe alopecia areata in adults

🇬🇧 MHRA · Fri 23 Oct 2026

The UK regulator approved the JAK inhibitor via the International Recognition Procedure for Sun Pharma UK. It later corrected the reported trial population to 1,209 patients.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved deuruxolitinib, marketed as Leqselvi, for adults with severe alopecia areata. The approval was granted on 10 March 2026 to Sun Pharma UK Limited and announced on 12 March. The agency updated its press release on 23 October 2026 to correct the number of trial participants from 1,223 to 1,209, which it described as a typographical error.

The MHRA says the product was authorised through the International Recognition Procedure (IRP), under which it can take account of decisions by other regulators. It is subject to additional monitoring so that new safety information can be identified quickly. The medicine is prescription-only, with a recommended dose of one 8 mg tablet twice a day.

The approval rests on two pivotal trials in 1,209 adults who had lost at least 50% of their scalp hair for more than six months. Participants took Leqselvi 8 mg, deuruxolitinib 12 mg or placebo twice daily for 24 weeks. At 24 weeks, patients on Leqselvi scored higher than placebo on a scalp hair scale. Around 30% had 80% or more scalp hair, and around 23% had 90% or more.

The most common side effects, which may affect more than 1 in 10 people, are headache and acne. The MHRA encourages anyone who suspects a side effect to tell a doctor, pharmacist or nurse and to report it through the Yellow Card scheme. Julian Beach, MHRA Executive Director, Healthcare Quality and Access, said: "As with any medicine, the MHRA will keep the safety and effectiveness of deuruxolitinib under close review." The agency says the Summary of Product Characteristics and patient information leaflet will be published on the MHRA Products website within seven days of approval.

What it means for your team

  • Pharmacovigilance teams should note the additional-monitoring status and the MHRA's call for Yellow Card reports of suspected side effects.
  • Regulatory teams can cite this approval as an example of a JAK inhibitor for alopecia areata reaching the UK market via the IRP.
  • Anyone who used the earlier press release should check the corrected trial population of 1,209 patients, not 1,223.
  • Market-access teams should consult the SmPC and patient leaflet on the MHRA Products website for full product information. The press release gives no detail on conditions of approval or post-authorisation commitments.

Official source: MHRA ↗

Article written by VigiEye from the official source (MHRA). AI-assisted; check the source before acting.

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