Press Release: Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia
Sanofi - American Depositary Shares (SNY)
US:NYSE Investor Relations:
sanofi.com/en/investors
Company Research
Source: GlobeNewswire
Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia Novel treatment targets BTK through multi-immune modulation to help address the underlying causes of ITPApproval based on the LUNA 3 phase 3 study that demonstrated rapid and durable platelet response and improvements in other ITP symptomsITP is a rare disease of complex immune dysregulation leading to lower platelet counts, bleeding, and reduced quality of life Paris, December 23, 2025 – The European Commission has approved Wayrilz (rilzabrutinib), a novel, oral, reversible, Bruton’s tyrosine kinase (BTK) inhibitor, as a new treatment for immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments. This follows the positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). Wayrilz can help address the underlying causes of ITP through multi-immune modulation, targeting different pathways across the immune system.
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- 12/23/25 - Form 6-K
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