The European Commission (EC) has approved a new indication for Praluent® (alirocumab), to reduce cardiovascular (CV) risk in adults with established atherosclerotic CV disease (ASCVD) by lowering low-density lipoprotein cholesterol (LDL-C) levels as an adjunct to correction of other risk factors.
The EC approval is based on data from ODYSSEY OUTCOMES, a Phase 3 CV outcomes trial that assessed the effect of adding Praluent to maximally-tolerated statins 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 trial met its primary endpoint, showing that Praluent significantly reduced the relative risk of major adverse CV events (MACE) by 15% in patients who had suffered a recent ACS. MACE occurred in 903 patients (9.5%) in the Praluent group and in 1,052 patients (11.1%) in the placebo group (HR 0.85; 95% CI, 0.78 to 0.93; p<0.001).
Additionally, Praluent was associated with a 15% lower risk of death from any cause; which occurred in 334 (3.5%) patients in the Praluent group and 392 (4.1%) patients in the placebo group (HR 0.85; 95% CI, 0.73 to 0.98; nominal significance). Adverse events were similar between the Praluent and placebo groups, except for injection site reactions (Praluent 3.8%, placebo 2.1%).
ASCVD 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.
ODYSSEY OUTCOMES UK Principal Investigator, Professor Kausik Ray, Professor of Public Health in the Department of Public Health and Primary Care at Imperial College London, and Honorary Consultant Cardiologist at the Imperial College NHS Trust, said: “The ODYSSEY OUTCOMES trial showed that using alirocumab to lower cholesterol can reduce the number of people who are at high risk of having another cardiovascular event. This is good news for patients and as clinicians, we must do everything we can to ensure the right patients get access to this treatment at the right time.”
Arunesh Sil, CV Medical Lead, Sanofi UK, said: “Alirocumab is already available across the UK as a treatment for primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia. Today’s announcement means that eligible patients who have a need for cholesterol lowering treatments beyond statins have the opportunity to benefit from alirocumab.”
Dr George D. Yancopoulos, Ph.D., President and Chief Scientific Officer, Regeneron, said: “In the large, prospective ODYSSEY OUTCOMES clinical trial, Praluent reduced the risk of major cardiovascular events, including heart attack, stroke and unstable angina, and was associated with reduced death from any cause.”