Alirocumab for Hyperlipidemia: Odyssey Phase Iii Clinical Trial Results and US Fda Approval Indications
Author:
- 20 January 2016
- journal article
- review article
- Published by Taylor & Francis in Future Cardiology
- Vol. 12 (2) , 115-128
Abstract
A new class of lipid-lowering drugs, inhibitors of proprotein convertase subtilisin kexin type 9 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 proprotein convertase subtilisin kexin type 9 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.Keywords
Funding Information
- Sanofi, Regeneron, Amgen and AstraZeneca and is on the speaker bureau for Sanofi, Regeneron, Amgen, AstraZeneca and Merck.
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