title: Alirocumab for hyperlipidemia: ODYSSEY Phase III clinical trial results and US FDA approval indications.
abstract: A new class of lipid-lowering drugs, inhibitors of PCSK9 has been generating impressive clinical trial data over the last several years, and alirocumab (Praluent) has become the first to be approved by the US FDA. Alirocumab has been shown to lower low density lipoprotein cholesterol by 45-62% with a safety profile generally comparable to placebo. Alirocumab is a monoclonal antibody to PCSK9 administered subcutaneously and has been evaluated in 16 Phase III clinical trials, the majority of which have been enrolled or completed. This article will be a review of the available Phase III safety and efficacy data of the ODYSSEY studies including a brief description of each of the 16 studies.
authors.affiliation: Cardiovascular Health & Disease Division, University of Cincinnati College of Medicine & Sterling Research Group, 375 Glensprings Drive 2nd Floor, Cincinnati, OH 45246, USA.
authors.forename: Eli M
authors.initials: EM
authors.lastname: Roth
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D017326:Clinical Trials, Phase III as Topic; D017277:Drug Approval; D006801:Humans; D006949:Hyperlipidemias / Q000188:drug therapy*
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C571059:alirocumab
keywords: LDL-C; ODYSSEY; PCSK9; SAR236553/REGN727; alirocumab; ezetimibe; hypercholesterolemia