The U.S. Food and Drug Administration today approved Praluent (alirocumab) injection, the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.

Praluent is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol.

HeFH is an inherited condition that causes high levels of low-density lipoprotein (LDL) cholesterol. A high level of LDL cholesterol (known as “bad” cholesterol) in the blood is linked to cardiovascular disease. Heart disease is the number one cause of death for Americans, both men and women. According to the Centers for Disease Control and Prevention, about 610,000 people die of heart disease in the United States every year– that equals one in every four deaths. 

“Praluent provides another treatment option for patients with HeFH or with known cardiovascular disease who have not been able to lower their LDL cholesterol enough on statins,” said John Jenkins, M.D., director of the Office of New Drugs, Center for Drug Evaluation and Research. “The FDA strongly supports continued work to provide new and innovative options for the treatment and prevention of cardiovascular disease.”

For more details, go to: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455883.htm