Sanofi and Regeneron Pharmaceuticals, Inc. 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 ODYSSEY 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 US. 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 been determined.
The global ODYSSEY programme 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 per cent versus placebo, and was generally well-tolerated with an acceptable safety profile.
The ODYSSEY OUTCOMES trial design was published in the American Heart Journal in November 2014.
In July, the companies announced that Praluent was approved for use in the US. 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. The effect of Praluent on CV morbidity and mortality has not been determined.
In September, the European Commission approved the marketing authorization for Praluent. In the EU, Praluent 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 Praluent on CV morbidity and mortality has not yet been determined.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.