Sanofi Hemophilia Drug Granted Priority Review by U.S. FDA
August 30 2022 - 1:28AM
Dow Jones News
By Cecilia Butini
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.
Write to Cecilia Butini at cecilia.butini@wsj.com
(END) Dow Jones Newswires
August 30, 2022 02:13 ET (06:13 GMT)
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