FDA approves expanded label for Regeneron/Sanofi's cholesterol drug

REUTERS: The U.S. Food and Drug Administration on Friday approved Regeneron Pharmaceuticals Inc's cholesterol drug Praluent as a treatment to cut the risk of heart attacks, stroke and other major cardiovascular events.

Praluent belongs to a class of injectable biotech drugs called PCSK9 inhibitors that dramatically lower bad LDL cholesterol and reduce the risk of heart attacks and death. In 2015, Praluent was approved in the United States for use as an add-on treatment to statin therapy in adults with heterozygous familial hypercholesterolemia, a condition that causes cholesterol levels in blood to shoot up. Sanofi and Regeneron in February cut the list price of Praluent by 60 percent to match the price of Amgen Inc's Repatha, another treatment to cut the risk of heart attacks, as the drugmakers try to boost the sales of the drug.

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