FDA approves Praluent injections to help lower cholesterol

The U.S. Food and Drug Administration late last week approved Praluent injections, the first cholesterol-lowering treatment cleared for use in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.

Praluent is approved for use in coordination with proper diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease who need to lower their LDL cholesterol levels.

HeFH is an inherited condition that causes high levels of low-density lipoprotein cholesterol. A high level of LDL cholesterol, also known as “bad” cholesterol, in the blood is linked to cardiovascular disease.

“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,” Dr. John Jenkins, director of the Office of New Drugs, Center for Drug Evaluation and Research, said. “The FDA strongly supports continued work to provide new and innovative options for the treatment and prevention of cardiovascular disease.”

The effectiveness and safety of Praluent were evaluated in five placebo-controlled trials involving 2,476 participants exposed to Praluent. All participants had HeFH or were otherwise at high risk for heart attack or stroke, and were taking maximally tolerated doses of a statin, with or without other lipid-modifying therapies. Participants taking Praluent had an average reduction in LDL cholesterol ranging from 36 to 59 percent, compared with a placebo.