Sanofi Hemophilia Drug Granted Priority Review by U.S. FDA

 Sanofi SA said Tuesday that the U.S. Food and Drug Administration has granted priority review to its hemophilia treatment efanesoctocog alfa.

The company had submitted a biologics license application--referring to an authorization to use and commercialize a biologic product--for the drug, which is used to prevent bleeds in people with hemophilia A. The FDA priority review means that the agency aims to take action on the application within six months, due to the significance of the drug to treat a serious disease.

Efanesoctocog alfa in May received breakthrough therapy designation from the FDA, Sanofi said. It was also labeled an orphan drug in both Europe and the U.S., meaning that the drug qualifies for special commercial conditions because of its importance in treating a rare disease.

The FDA's decision on efanesoctocog alfa is set for Feb. 28, 2023, Sanofi said.

https://www.marketscreener.com/quote/stock/SANOFI-4698/news/Sanofi-Hemophilia-Drug-Granted-Priority-Review-by-U-S-FDA-41645757/