Regeneron, Sanofi Announce 18,000-Patient ODYSSEY OUTCOMES Trial of Praluent Injection Fully Enrolled

Regeneron Pharmaceuticals, Inc. 

and Sanofi

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 Praluent® (alirocumab) Injection after an acute coronary syndrome (ACS). The 18,000-patient OUTCOMES trial is expected to be completed in 2017. ODYSSEY OUTCOMES is designed to determine whether the addition of Praluent 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. Praluent is currently approved in the U.S. and EU to reduce bad (LDL) cholesterol in some patients with significant unmet need, including those with established cardiovascular disease, or an inherited form of high cholesterol, called heterozygous familial hypercholesterolemia (HeFH). The effect of Praluent on CV morbidity and mortality has not yet been determined.