New Treatment Approved for Alopecia Areata
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for deuruxolitinib, marketed as Leqselvi, as a treatment for severe alopecia areata in adults. This condition is characterised by the immune system attacking hair follicles, resulting in inflammation and significant hair loss from the scalp, face, and other areas of the body.
Mechanism of Action
Deuruxolitinib functions by modulating the activity of specific enzymes, namely JAK1, JAK2, and TYK2, while reducing the influence of JAK3 kinases, which play a crucial role in the inflammatory processes affecting hair follicles. This mechanism helps to alleviate inflammation, thereby promoting hair regrowth in individuals suffering from alopecia areata.
Official Comment on Approval
Julian Beach, Executive Director for Healthcare Quality and Access at the MHRA, remarked, “This approval provides adults with alopecia areata with an additional potential treatment option to help manage their condition. As with any medication, the MHRA will continue to monitor the safety and effectiveness of deuruxolitinib closely.”
He further noted that deuruxolitinib is available only through prescription, with the advised dosage being an 8 mg tablet taken twice daily.
Clinical Trials and Efficacy
The efficacy of this medication was demonstrated in two pivotal clinical trials involving 1,209 adult participants who had experienced a minimum of 50% hair loss for over six months. In these studies, participants received either Leqselvi at 8 mg, deuruxolitinib at 12 mg, or a placebo, administered twice daily over a 24-week period.
Results indicated that those receiving Leqselvi reported significantly higher scores on a scale measuring scalp hair growth compared to those on placebo. Approximately 30% of patients treated with Leqselvi experienced an 80% or greater regrowth of scalp hair, while around 23% achieved 90% or more regrowth after the treatment period.
Potential Side Effects
Common side effects associated with deuruxolitinib, affecting more than 10% of users, include headaches and acne. Patients experiencing side effects are encouraged to consult their healthcare provider or pharmacist and to report any adverse effects through the Yellow Card scheme, which can be accessed online or via mobile apps available on major platforms.
Additional Information for Patients
Deuruxolitinib received its approval on 10 March 2026 from Sun Pharma UK Limited. This medication was evaluated through the International Recognition Procedure (IRP) and is subject to additional monitoring to facilitate the prompt identification of any new safety information. Further details can be found in the Summary of Product Characteristics and Patient Information leaflets, which will be available on the MHRA Products website within a week of approval.
About the MHRA
The MHRA is the regulatory body responsible for overseeing all medicines and medical devices in the UK, ensuring their efficacy and safety. The agency’s operations are grounded in thorough and evidence-based assessments to ensure that the advantages of any treatment outweigh the associated risks. The MHRA operates as an executive agency under the Department of Health and Social Care.
For media inquiries, please reach out via newscentre@mhra.gov.uk or call 020 3080 7651.