07:49 AM EDT, 10/17/2025 (MT Newswires) -- Sanofi ( SNY ) said Friday that a European Medicines Agency committee has recommended the approval for Wayrilz, or rilzabrutinib, to treat adults with immune thrombocytopenia who are refractory to other treatments.

The recommendation is based on data from a phase 3 study that showed "rapid and durable" platelet response and improvements in bleeding and other symptoms, the company said. A final European Union decision is likely in the coming months.

Wayrilz is already approved in the US and United Arab Emirates, and is under regulatory review in China.

Immune thrombocytopenia is a disease of complex immune dysregulation that causes low platelet counts.