LONDON, May 29 -- The government of the United Kingdom issued the following news:

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (29 May2026)granted a marketing authorisation forthe medicines rilzabrutinib (Wayrilz) to treatadults with immune thrombocytopenia (ITP) when prior treatments for ITP have not worked well enough.

ITP is arareautoimmune disease, in which the body's own immune system attacks and destroys platelets in the blood, causes fatigue, and increases risk of bleeding. Platelets are needed to help create clots and stop bleeding.

Rilzabrutinibworks by blockingBruton's tyrosine kinase,a protein in the bodythat plays a role in the immune system. By blocking this protein, the medicine can decrease the destruction of blood platelets andthusincrease the number of healthy platelets in the body. This helps reduce the risk of bleeding.

Julian Beach, MHRA Executive Director, Healthcare Quality and Access, said:

Keeping patients safe and enabling their access to high quality, safe,and effective medical products are key priorities forus.

TheMHRA hasdecided thatthebenefitsofrilzabrutinibare greater than its risks and that it can be authorised for use in theUK.

As with all products,wewill keep the safety and effectiveness ofrilzabrutinibunder close review.

Rilzabrutinibis available as tablets to be taken by mouth twice a day.

This approval is based on a pivotal phase 3 study of 202 patients with ITP whose prior treatments had been insufficient. After 24 weeks, 23 per cent of patients receivingrilzabrutinibachieved a stable, adequate platelet count to prevent excessive bleeding, compared with 0 per cent on placebo.

The most common side effects of the medicine (which may affect more than 1 in 10 people) includediarrhoea, nose and throat infections, nausea, headache, stomach pain,and jointpain.

Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly 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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Thenew marketingauthorisationwasgranted on29 May 2026to Sanofi B.V

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More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on theMHRA Products websitewithin 7 days of approval.  

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This application was approved under International RecognitionProcedure (IRP).For more information, visit:International Recognition Procedure - GOV.UK

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For more information aboutimmune thrombocytopenia (ITP), visit:Immune thrombocytopenic purpura.

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The Medicines and Healthcare products Regulatory Agency (MHRA)is responsible forregulating 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 thenewscentre@mhra.gov.uk, or call on 020 3080 7651.

Disclaimer: Curated by HT Syndication.