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Regeneron and Sanofi partnership announces full enrollment of 18,000 patient ODYSSEY OUTCOMES trial of Praluent Injection
25 November 2015 -

Biopharmaceutical company Regeneron Pharmaceuticals (Nasdaq:REGN) said on Tuesday that it has completed enrollment under its global Phase 3 ODYSSEY OUTCOMES trial that is evaluating the potential cardiovascular (CV) benefits of Praluent (alirocumab) Injection after an acute coronary syndrome (ACS) in partnership with Sanofi.

The company said Praluent is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or clinical atherosclerotic CVD, who require additional lowering of LDL cholesterol.

Following the enrollment, the 18,000-patient OUTCOMES trial is expected to be completed in 2017, added the companies.

Under the global ODYSSEY programme, the 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 programme includes 16 Phase 3 trials at2,000 study centres and once complete will evaluate more than 25,000 patients.

In completed trials, Praluent reduced LDL cholesterol by up to an additional 62% versus placebo and was generally well-tolerated with an acceptable safety profile, disclosed the company.

According to the companies, the primary endpoint of ODYSSEY programme 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.