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Sanofi and Regeneron's Praluent approved in Europe to reduce CV risk

Published on 18/03/19 at 10:32am

Sanofi and Regeneron’s Praluent (alirocumab) has been awarded approval by the European Commission, it has emerged, as a therapy to reduce cardiovascular risk in patients with established atherosclerotic CV disease (ASCVD) by lowering low-density lipoprotein cholesterol (LDL-C) levels as an adjunct to correction of other risk factors.

ASCVD refers to a build-up of plaque in the arteries which can reduce blood flow and lead to a range of conditions including peripheral artery disease, acute coronary syndrome (ACS) and stroke.

Phase 3 data submitted in support of the decision was derived from 18,924 patients who experienced an ACS within one year prior to enrolment. They showed that Praluent, when added to maximally-tolerated statins, “significantly reduced the relative risk of major adverse CV events (MACE) by 15% in patients who had suffered a recent ACS”, meeting the trial’s primary endpoint.

Throughout the study, 9.5% of Praluent patients experienced MACE, compared to 11.1% in the placebo group. Praluent was shown to reduce risk of death from any cause by 15%, with 3.5% death occurring in the drug’s group versus 4.1% in the placebo group.

"Despite treatment with the current standard of care including statins, many Europeans with established cardiovascular disease are still unable to control their cholesterol," said Dr George D Yancopoulos, President and Chief Scientific Officer at Regeneron. "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.”

Dr John Reed, Global Head of Research & Development at Sanofi, also remarked: “Many patients with atherosclerotic cardiovascular disease often struggle to control their high LDL-cholesterol levels, despite lifestyle modifications and treatment with statins, and some have already experienced cardiovascular events. These patients could face a higher risk of another life-threatening cardiovascular event, and Praluent's new indication in Europe offers a risk-reduction focused lipid-lowering treatment option to physicians and patients.”

Matt Fellows

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