- Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NASDAQ:SNY) announce the completed enrollment of ~18,000 patients in their global Phase 3 study, ODYSSEY OUTCOMES, evaluating the potential cardiovascular (CV) benefits of cholesterol fighter Praluent (alirocumab) after an acute coronary syndrome (ACS). The trial is designed to determine if the addition of Praluent to intensive statin therapy reduces major adverse cardiac events in patients who have had an ACS (e.g., heart attack or unstable angina). The primary endpoint is time to first occurrence of coronary heart disease death, acute myocardial infarction (heart attack), hospitalization for unstable angina or fatal or non-fatal ischemic stroke. The study should be completed in 2017.
- The global ODYSSEY program includes 16 Phase 3 trials conducted across more than 2,000 medical centers around the world. More than 25,000 patients will be evaluated.