FDA Approves First Single Injection PCSK9 Inhibitor Delivery System

The U.S. Food and Drug Administration (FDA) has approved Amgen’s evolocumab (Repatha) Pushtronex system, which delivers a proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor once per month. The hands-free system is the first of its kind and delivers 420 mg of evolocumab in a single dose.

Evolocumab received FDA approval in August 2015 as a treatment to lower low-density lipoprotein cholesterol – in addition to diet and maximally-tolerated statin therapy – in patients with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease.

According to Amgen, the system will be available in August 2016.

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention, Lipid Metabolism, Nonstatins, Novel Agents, Primary Hyperlipidemia, Statins, Diet

Keywords: Antibodies, Monoclonal, Cardiovascular Diseases, Cholesterol, LDL, Diet, Dyslipidemias, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hyperlipoproteinemia Type II, Proprotein Convertases, Saccharomyces cerevisiae Proteins, Subtilisin, United States Food and Drug Administration, Secondary Prevention, Metabolic Syndrome X

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