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

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The FDA’s decision will allow the drug, developed by Regeneron along with Sanofi SA, to be prescribed to reduce the overall risk of major adverse cardiovascular events (MACE)

The U.S. Food and Drug Administration on Friday approved Regeneron Pharmaceuticals’s cholesterol drug Praluent as a treatment to cut the risk of heart attacks, stroke and other major cardiovascular events. The FDA’s decision will allow the drug, developed along with Sanofi SA, to be prescribed to reduce the overall risk of major adverse cardiovascular events (MACE).

MACE includes heart attack, ischemic stroke, coronary heart disease and unstable chest pains requiring hospitalization.

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.

The FDA also approved Praluent as an adjunct to diet, alone or in combination with other lipid-lowering therapies, for the treatment of adults with primary hyperlipidemia to reduce LDL-C.

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.

The new list price for Praluent will be $5,850 a year, down from more than $14,000 a year, when it was first approved in 2015.

Sales of both Praluent and Repatha have been severely constrained by roadblocks put up by insurers looking to limit spending on the expensive drugs.

Praluent has been approved in more than 60 countries worldwide, including the U.S., Japan, Canada, Switzerland, Mexico and Brazil, as well as the European Union.

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