Sanofi's Wayrilz Wins EU Approval as First BTK Inhibitor for Immune Thrombocytopenia

Reuters
2025.12.23 14:07
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Sanofi's Wayrilz (rilzabrutinib) has received European Commission approval as the first BTK inhibitor for treating immune thrombocytopenia (ITP) in adults refractory to other treatments. This approval is based on the LUNA 3 phase 3 study results and follows a positive opinion from the European Medicines Agency. Wayrilz is also approved in the US and UAE, with reviews ongoing in Japan and China.