Sanofi (SNY) Secures Japan Marketing Rights for Wayrilz in ITP

Sanofi (SNY) announced on June 23, 2026, it received marketing approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for Wayrilz (rilzabrutinib). The drug is approved for treating primary immune thrombocytopenia (ITP) in adults who have shown an inadequate response to prior therapies. This marks a significant regulatory milestone for Sanofi in the Japanese market. Wayrilz is an oral Bruton's tyrosine kinase (BTK) inhibitor. The approval is based on results from the global Phase 3 LUNA 3 study, which demonstrated the drug's efficacy and safety profile. Immune thrombocytopenia is a rare autoimmune bleeding disorder characterized by a low platelet count, increasing the risk of bruising and bleeding. This approval expands Sanofi's hematology portfolio and offers a new treatment option for Japanese patients.