Rilzabrutinib authorised to treat adults with immune thrombocytopenia when prior treatments have been insufficient听
As with any medicine, the MHRA will keep the safety and effectiveness of rilzabrutinib under close review.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (29 May听2026)听granted a marketing authorisation for听the medicines rilzabrutinib (Wayrilz) to treat听adults with immune thrombocytopenia (ITP) when prior treatments for ITP have not worked well enough.听听
ITP is a听rare听autoimmune disease, in which the body麓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.听
Rilzabrutinib听works by blocking听Bruton鈥檚 tyrosine kinase,听a protein in the body听that plays a role in the immune system. By blocking this protein, the medicine can decrease the destruction of blood platelets and听thus听increase the number of healthy platelets in the body. This helps reduce the risk of bleeding.听
Julian Beach, MHRA Executive Director, Healthcare Quality and Access, said:听
Keeping patients safe and enabling their access to high quality, safe,听and effective medical products are key priorities for听us.听听
The听MHRA has听decided that听the听benefits听of听rilzabrutinib听are greater than its risks and that it can be authorised for use in the听UK.听
As with all products,听we听will keep the safety and effectiveness of听rilzabrutinib听under close review.
Rilzabrutinib听is available as tablets to be taken by mouth twice a day.听
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 receiving听rilzabrutinib听achieved a stable, adequate platelet count to prevent excessive bleeding, compared with 0 per cent on placebo.听
The most common side effects of the medicine鈥�(which may affect more than 1 in 10 people) include听diarrhoea, nose and throat infections, nausea, headache, stomach pain,听and joint听pain.听听
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听() or by searching the Google Play or Apple App stores for MHRA Yellow Card.鈥�
Notes to editors鈥��
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The听new marketing听authorisation听was听granted on听29 May 2026听to Sanofi B.V听
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More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the听听within 7 days of approval.鈥��
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This application was approved under International Recognition听Procedure (IRP).听For more information, visit:听International Recognition Procedure - 扒哥吃瓜听
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For more information about听immune thrombocytopenia (ITP), visit:听.听
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The Medicines and Healthcare products Regulatory Agency (MHRA)听is responsible for听regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.鈥� All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.鈥��
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The MHRA is an executive agency of the Department of Health and Social Care.鈥��
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For media enquiries, please contact the听newscentre@mhra.gov.uk, or call on 020 3080 7651.