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USFDA Clears Sanofi's Bleeding Disease Therapy

The U.S. Food and Drug Administration has approved Sanofi SA's therapy to treat a type of inherited bleeding disorder known as hemophilia A and expects to launch it in the United States in April, the French drugmaker said on Thursday.

Sanofi's replacement therapy - Altuviiio - is entering a market dominated by rivals like Takeda Pharmaceutical, Bayer AG and Novo Nordisk, which sell factor replacement therapies that have been the standard treatment for decades.

Factor replacement therapies replace the missing blood clotting factor so that blood can clot properly by injecting treatment products into a person's vein. Sanofi's drug is likely to be considered one of the best in that class, said Damien Conover, Morningstar analyst, ahead of the approval.

(Reuters)

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