The ODYSSEY outcomes trial is designed to prospectively assess the effect of alirocumab on cardiovascular events in high-risk patients. Based on an announcement of Sanofi and Regeneron Pharmaceuticals, Inc., the ongoing Praluent (alirocumab) ODYSSEY outcomes trial will continue as planned, based on the recommendation of an independent Data Monitoring Committee (DMC) after it completed a second pre-specified interim analysis. The DMC will continue to monitor the ongoing safety and efficacy of alirocumab as planned. The Phase 3, multi-center, randomized, double-blind, placebo-controlled ODYSSEY outcomes trial involves more than 18,000 patients from 57 countries. All patients who entered the trial had experienced a heart attack or unstable angina requiring hospitalization within a year of entering the trial, and were unable to control their LDL cholesterol despite receiving maximally-tolerated statins and potentially other lipid-lowering therapies. Patients receiving maximally-tolerated statin therapy were randomized to receive either alirocumab 75 milligrams (mg) every two weeks or placebo. Patients on alirocumab had their dose increased to 150 mg every two weeks at week 8 if their LDL cholesterol remained above 50 milligrams/deciliter (mg/dL).
Alirocumab is a human monoclonal antibody that inhibits the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to the LDL receptor and thereby increases the number of available LDL receptors on the surface of liver cells, which results in lower LDL cholesterol levels in the blood.It is the only PCSK9 inhibitor available in two dosages with two levels of efficacy (75 mg and 150 mg), allowing physicians to select the dose based on a patient’s LDL cholesterol lowering needs. Praluent is currently approved in approximately 40 countries worldwide, including the U.S., Japan, Canada, Switzerland, Mexico, Brazil and the European Union (EU). In the U.S., alirocumab is approved for use as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic CV disease, who require additional lowering of LDL cholesterol. In the E.U., alirocumab is approved for the treatment of adult patients with primary hypercholesterolemia (HeFH and non-familial) or mixed dyslipidemia as an adjunct to diet: a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL cholesterol goals with the maximally-tolerated statin or b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated. The effect of alirocumab on CV morbidity and mortality has not yet been determined.