FDA Approves Alirocumab (Praluent) for Certain Patients with Hypercholesterolemia

Following a June 2015 recommendation by the U.S Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee, the FDA has approved alirocumab for patients on maximally tolerated statin therapy with heterozygous familial hypercholesterolemia (HeFH) or with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol. Alirocumab is produced by Sanofi and Regeneron, and known by the brand name Praluent.

 

In the press release from the FDA, the FDA states that “the efficacy 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 to placebo.”

 

Alirocumab is the first drug in its class to be approved in the United States. The decision on a second drug, evolocumab, which is produced by Amgen and marketed as Repatha, is scheduled to be announced later in August.  

 

Click here to read the FDA press release.