Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia

Sanofi

23 December 2025 - Approval based on the LUNA 3 Phase 3 study that demonstrated rapid and durable platelet response and improvements in other immune thrombocytopenia symptoms.

The European Commission has approved Wayrilz (rilzabrutinib), a novel, oral, reversible, Bruton’s tyrosine kinase inhibitor, as a new treatment for immune thrombocytopenia in adult patients who are refractory to other treatments.

Read Sanofi press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , Europe , Registration