(Reuters) -The U.S. Food and Drug Administration (FDA) has approved French drugmaker Sanofi SA’s therapy to treat a type of inherited bleeding disorder known as hemophilia A, according to the regulator’s letter dated Wednesday.
With the approval, Sanofi’s replacement therapy enters a market dominated by rivals like Shire, 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.
The approval also provides patients an alternative to Roche’s blockbuster drug, Hemlibra, which is the market leader for this indication.
Hemophilia A is a genetic disorder caused by missing or defective factor VIII, a clotting protein.
Sanofi did not immediately respond to a Reuters request for comment on the regulatory approval.
(Reporting by Sriparna Roy and Khushi Mandowara in Bengaluru; Editing by Shinjini Ganguli and Shailesh Kuber)
