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Alirocumab (Praluent) Wins FDA Nod for Treatment of Certain Patients With High Cholesterol

First in a new class of injectable cholesterol-lowering drugs

The FDA has given the green light to alirocumab (Praluent, Sanofi-Aventis/Regeneron Pharmaceuticals) injection, the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.

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

HeFH is an inherited condition that causes high levels of LDL-C. A high concentration of LDL-C in the blood is linked to cardiovascular disease. Heart disease is the number one cause of death in Americans, both men and women. According to the Centers for Disease Control and Prevention, approximately 610,000 people die of heart disease in the U.S. each year –– accounting for one in every four deaths.

Alirocumab is an antibody that targets the PCSK9 protein, which reduces the number of receptors on the liver that remove LDL-C from the blood. By blocking the ability of PCSK9 to work, more receptors are available to remove LDL-C cholesterol from the blood and, as a result, lower LDL-C levels.

The efficacy and safety of alirocumab were evaluated in five placebo-controlled trials involving a total of 2,476 participants exposed to the drug. All of the participants had HeFH or were otherwise at a high risk for heart attack or stroke, and were taking maximally tolerated doses of a statin, with or without other lipid‑modifying therapies. The subjects receivng alirocumab had average reductions in LDL-C levels ranging from 36% to 59% compared with placebo. 

Numerous clinical trials have demonstrated that statins lower the risk of having a heart attack or stroke. A trial investigating the effects of adding alirocumab to statins on cardiovascular risk reduction is ongoing.

The most common adverse events associated with alirocumab include injection-site itching, swelling, pain, or bruising; nasopharyngitis; and flu. Allergic reactions, such as vasculitis and hypersensitivity reactions requiring hospitalization, have been reported with the use of alirocumab. Patients should stop using alirocumab and get medical help if they experience symptoms of a serious allergic reaction.

Source: FDA; July 24, 2015.

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