ODYSSEY: a study to assess the potenital cardiovascular benefit of alirocumab

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Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the companies have completed enrollment in the global Phase 3 ODYSSEY OUTCOMES trial, which is prospectively evaluating the potential cardiovascular (CV) benefits of alirocumab after an acute coronary syndrome (ACS). The 18,000-patient ODYSSEY OUTCOMES trial is expected to be completed in 2017. ODYSSEY OUTCOMES is designed to determine whether the addition of alirocumab to intensive statin therapy reduces major adverse cardiac events among patients who had previously experienced an ACS, such as a heart attack or unstable angina. The primary endpoint evaluates the time to first occurrence of coronary heart disease death, acute myocardial infarction, hospitalization for unstable angina, or fatal and non-fatal ischemic stroke. Patients with recent ACS were selected as the study population because they face a higher risk of recurrent events than patients with stable cardiovascular disease. The global ODYSSEY program includes 16 Phase 3 trials conducted at more than 2,000 study centers, around the world, and once complete will evaluate more than 25,000 patients. Data from this program helped form one of the most comprehensive data sets ever used for the initial regulatory filing of a cholesterol-lowering therapy. In completed trials, Praluent reduced LDL cholesterol by up to an additional 62 percent versus placebo, and was generally well-tolerated with an acceptable safety profile.

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