The MHRA in the UK authorises Wayrilz (rilzabrutinib) for the treatment of adults with immune thrombocytopenia when prior treatments have been insufficient – Sanofi

The MHRA confirmed that it granted a UK marketing authorisation to Wayrilz (rilzabrutinib) for adults with immune thrombocytopenia (ITP) whose previous treatments have not worked sufficiently. The approval was granted to Sanofi.

ITP is a rare autoimmune 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. Rilzabrutinib works by blocking Bruton’s tyrosine kinase, a protein in the body that plays a role in the immune system. By blocking this protein, the medicine can decrease the destruction of blood platelets and thus increase the number of healthy platelets in the body. This helps reduce the risk of bleeding.

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