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Sanofi, Regeneron Begin Enrollment in CV Outcomes Trial with PCSK9 Antibody for Hypercholesterolemia

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Sanofi (NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the ODYSSEY OUTCOMES trial, a Phase 3 cardiovascular outcomes trial (CVOT) with SAR236553/REGN727 is now recruiting patients. SAR236553/REGN727 is an investigational subcutaneously administered, fully-human antibody that is being evaluated for its impact on lowering low-density lipoprotein cholesterol (LDL-C) by targeting PCSK9 (proprotein convertase subtilisin/kexin type 9).

The ODYSSEY OUTCOMES trial will enroll approximately 18,000 patients, who recently suffered an acute coronary syndrome (ACS), from 49 countries across six continents. With the start of this study, eleven trials are now recruiting in the global SAR236553/REGN727 Phase 3 program.

Posted-In: News FDA


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