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Sanofi and Regeneron report 18-month results of ODYSSEY long term trial of Praluent

Sanofi and Regeneron Pharmaceuticals have reported positive 18-month results of a Phase III ODYSSEY long term trial of Praluent (alirocumab), an investigational therapy, in patients with hypercholesterolemia.

The trial evaluated Praluent 150mg every two weeks compared to placebo in patients who were at high cardiovascular (CV) risk and who were receiving maximally-tolerated statin therapy with or without other lipid-lowering treatment.

In the trial, which included 2,341 high risk hypercholesterolemia patients, consumption of Praluent 150mg every two weeks reduced low-density lipoprotein cholesterol (LDL-C) by an additional 62% at week 24 when compared to placebo, the primary efficacy endpoint of the trial, with consistent LDL-C lowering maintained over 78 weeks.

University of Iowa director of the Prevention Intervention Center, Professor, Departments of Epidemiology & Medicine, College of Public Health Jennifer Robinson said: "These results demonstrated the durable efficacy for Praluent when added to maximally-tolerated statin therapy and further reinforce its generally consistent safety profile.

"Additionally, the post hoc analysis of major cardiovascular events represents an important finding for Praluent — we look forward to results from the ongoing ODYSSEY OUTCOMES trial, which is prospectively evaluating the potential of Praluent to reduce cardiovascular events."

During the trial, patients received 78 weeks of treatment followed by an eight-week safety assessment.

The company said that patients self-administered a subcutaneous injection every two weeks via a pre-filled syringe.