Alirocumab receives EC approval in established atherosclerotic cardiovascular disease

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The European Commission (EC) has approved the use of alirocumab (Praluent, Sanofi), a PCSK9 inhibitor, in adults with established atherosclerotic cardiovascular disease (ASCVD) to lower low-density lipoprotein cholesterol (LDL-C) levels, reducing cardiovascular risk.
Approximately seven million people have cardiovascular disease in the UK, with 160,000 deaths annually. Atherosclerotic cardiovascular disease can lead to a number of serious conditions such as stroke, peripheral artery disease and acute coronary syndrome (ACS).
The approval is based on data from the ODYSSEY OUTCOMES trial which assessed the effect of alirocumab in 18,924 people who had an acute coronary syndrome between one and 12 months before enrolling in the trial and who were already on intensive or maximally-tolerated statin treatment. The data, published in the New England Journal of Medicine, found that alirocumab significantly reduced the risk of major adverse cardiovascular events (MACE) by 15% (hazard ratio [HR] 0.85;95% confidence interval [CI] 0.78–0.93; p<0001) compared to placebo. The primary endpoint was a composite of death from coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalisation. The safety profile in ODYSSEY OUTCOMES was consistent with the overall safety profile described with the previous phase III controlled trials.
ODYSSEY OUTCOMES UK principal investigator Professor Kausik Ray (Department of Public Health and Primary Care, Imperial College London,UK) said: “Cardiovascular disease is one of the UK’s biggest killers and one in four people will die early as a result. There is a need for additional treatment options for those who can’t use or tolerate statins, or for whom statins are not enough to bring their cholesterol levels within the recommended range. 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.”


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