Sanofi and Regeneron complete enrolment for global Praluent trial

Sanofi and Regeneron have announced that enrolment for their global trial assessing potential cardiovascular benefits of their drug Praluent has now been completed.

The phase III ODYSSEY OUTCOMES trial is prospectively evaluating cardiovascular benefits associated with Praluent injection after an acute coronary syndrome (ACS). Involving 18,000 patients, the trial is expected to be completed in 2017.

Specifically, it will examine 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.

Patients with recent ACS were selected as the study population because they face a higher risk of recurrent events than those with stable cardiovascular disease.This trial forms part of the wider ODYSSEY study programme, which consists of 16 phase III trials in total.

The drug is currently approved in the US and EU to reduce bad cholesterol levels in certain patients with significant unmet need, including those with established cardiovascular disease or heterozygous familial hypercholesterolaemia, an inherited form of high cholesterol.