CHMP recommends Praluent to reduce risk of established atherosclerotic cardiovascular disease. Sanofi + Regeneron

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Praluent (alirocumab), from Sanofi + Regeneron, recommending a new indication as an adjunct to correction of other risk factors. Praluent should be used in addition to a maximally tolerated dose of statin or can be used alone in patients intolerant to or inappropriate for statin therapy.

ASCVD (atherosclerotic cardiovascular disease) is an umbrella term, defined as a build-up of plaque in the arteries that can lead to reduced blood flow and a number of serious conditions such as stroke, peripheral artery disease and acute coronary syndrome (ACS), which includes heart attack and unstable angina.

The CHMP opinion is based on data from ODYSSEY OUTCOMES, a Phase III cardiovascular outcomes trial that assessed the effect of Praluent in 18,924 patients who had an ACS between 1-12 months (median 2.6 months) before enrolling in the trial. Results from the ODYSSEY OUTCOMES trial were published in The New England Journal of Medicine in 2018.The European Commission is expected to make a final decision in the coming months. Data from ODYSSEY OUTCOMES has also been submitted to the FDA, with a target action date of April 28, 2019.