FDA Approves Second PCSK9 Inhibitor

The U.S. Food and Drug Administration (FDA) on August 27 approved Amgen’s Repatha (evolocumab) as a treatment to lower low-density lipoprotein cholesterol in patients with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease. This is the second proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor approved this year, following the approval of the Praluent (alirocumab) injection in July.

According to the FDA, the new drug should be used in addition to diet and maximally-tolerated statin therapy. Side effects of this PCSK9 inhibitor include nasopharyngitis, upper respiratory tract injection, flu, back pain and bruising at the site of injection.

Read the FDA announcement.

Clinical Topics: Dyslipidemia, Prevention, Homozygous Familial Hypercholesterolemia, Lipid Metabolism, Nonstatins, Novel Agents, Primary Hyperlipidemia, Statins, Diet

Keywords: Antibodies, Monoclonal, Atherosclerosis, Back Pain, Cholesterol, Cholesterol, LDL, Diet, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hyperlipoproteinemia Type II, Lipoproteins, LDL, Nasopharyngitis, Proprotein Convertases, Respiratory System, Subtilisins, United States Food and Drug Administration, Diabetes Mellitus, Hypercholesterolemia, Obesity

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