The Medicines and Healthcare products Regulatory Agency (MHRA) has today (29 May\u00a02026)\u00a0granted a marketing authorisation for\u00a0the medicines rilzabrutinib (Wayrilz) to treat\u00a0adults with immune thrombocytopenia (ITP) when prior treatments for ITP have not worked well enough.\u00a0\u00a0<\/p>\n
ITP is a\u00a0rare\u00a0autoimmune disease, in which the body\u00b4s 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.\u00a0<\/p>\n
Rilzabrutinib\u00a0works by blocking\u00a0Bruton\u2019s tyrosine kinase,\u00a0a protein in the body\u00a0that plays a role in the immune system. By blocking this protein, the medicine can decrease the destruction of blood platelets and\u00a0thus\u00a0increase the number of healthy platelets in the body. This helps reduce the risk of bleeding.\u00a0<\/p>\n
Julian Beach, MHRA Executive Director, Healthcare Quality and Access, said:\u00a0<\/p>\n
Keeping patients safe and enabling their access to high quality, safe,\u00a0and effective medical products are key priorities for\u00a0us.\u00a0\u00a0<\/p>\n
The\u00a0MHRA has\u00a0decided that\u00a0the\u00a0benefits\u00a0of\u00a0rilzabrutinib\u00a0are greater than its risks and that it can be authorised for use in the\u00a0UK.\u00a0<\/p>\n
As with all products,\u00a0we\u00a0will keep the safety and effectiveness of\u00a0rilzabrutinib\u00a0under close review.<\/p>\n
Rilzabrutinib\u00a0is available as tablets to be taken by mouth twice a day.\u00a0<\/p>\n
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\u00a0rilzabrutinib\u00a0achieved a stable, adequate platelet count to prevent excessive bleeding, compared with 0 per cent on placebo.\u00a0<\/p>\n
The most common side effects of the medicine\u202f(which may affect more than 1 in 10 people) include\u00a0diarrhoea, nose and throat infections, nausea, headache, stomach pain,\u00a0and joint\u00a0pain.\u00a0\u00a0<\/p>\n
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\u00a0(https:\/\/yellowcard.mhra.gov.uk\/<\/a>) or by searching the Google Play or Apple App stores for MHRA Yellow Card.\u202f\u00a0<\/p>\n Notes to editors\u202f\u202f\u00a0<\/p>\n The\u00a0new marketing\u00a0authorisation\u00a0was\u00a0granted on\u00a029 May 2026\u00a0to Sanofi B.V\u00a0<\/p>\n More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the\u00a0MHRA Products website<\/a>\u00a0within 7 days of approval.\u202f\u202f\u00a0<\/p>\n This application was approved under International Recognition\u00a0Procedure (IRP).\u00a0For more information, visit:\u00a0International Recognition Procedure – GOV.UK<\/a>\u00a0<\/p>\n For more information about\u00a0immune thrombocytopenia (ITP), visit:\u00a0Immune thrombocytopenic purpura<\/a>.\u00a0<\/p>\n The Medicines and Healthcare products Regulatory Agency (MHRA)\u00a0is responsible for\u00a0regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.\u202f All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.\u202f\u202f\u00a0<\/p>\n The MHRA is an executive agency of the Department of Health and Social Care.\u202f\u202f\u00a0<\/p>\n