Sanofi wins drug approvals in Japan and the EU for two specialty therapies

Regulation
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Sanofi has secured regulatory approval in Japan for Wayrilz, also known as rilzabrutinib, to treat chronic immune thrombocytopenia, and in the European Union for Cenrifki, or tolebrutinib, for progressive multiple sclerosis including secondary progressive MS. Both are oral Bruton's tyrosine kinase inhibitors that expand the company's immunology and neurology portfolio, targeting chronic conditions with high unmet medical need. The approvals arrive as Sanofi's share price stands at €73.47, down 10.8% year to date and 7.3% over the past year. Cenrifki carries a known risk of drug-induced liver injury requiring strict monitoring, while Wayrilz is also being investigated for additional rare disease indications such as IgG4-related disease and warm autoimmune hemolytic anemia. Investors will now watch early prescribing trends, reimbursement decisions, and post-marketing safety data to gauge how these products contribute to Sanofi's specialty care mix.

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Sanofi won regulatory approvals in Japan and the EU for two specialty therapies, expanding its immunology and neurology portfolio.

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