Press Release: Sanofi's Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia [Yahoo! Finance]
Sanofi - American Depositary Shares (SNY)
US:NYSE Investor Relations:
sanofi.com/en/investors
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Source: Yahoo! Finance
Novel treatment targets BTK through multi-immune modulation to help address the underlying causes of ITP Approval based on the LUNA 3 phase 3 study that demonstrated rapid and durable platelet response and improvements in other ITP symptoms ITP 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. “ITP is caused by complex immune system dysregulation leading to low platelet counts,
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SNY
Sec Filings
- 12/23/25 - Form 6-K
- 12/22/25 - Form 6-K
- 12/15/25 - Form 6-K
- SNY's page on the SEC website