Regeneron Pharmaceuticals and Sanofi have secured approval for Praluent (alirocumab) for a new indication from the European Commission (EC), which is for the reduction of cardiovascular risk in adults with established atherosclerotic CV disease (ASCD) by reducing low-density lipoprotein cholesterol (LDL-C) levels as an adjunct to correct other risk factors.
Atherosclerotic CV Disease is defined as the build-up of plaque in the arteries that leads to reduced blood flow and many serious conditions like stroke, peripheral artery disease and acute coronary syndrome (ACS) including heart attack and unstable angina.
The latest EC approval for Praluent (alirocumab) is based on the findings of the phase 3 CV outcomes trial called ODYSSEY OUTCOMES that evaluated the effect of adding Praluent to maximally tolerated statins. The late-stage trial featured 18,924 patients, who had an ACS between 1-12 months before their enrolment.
The ODYSSEY OUTCOMES met its primary endpoint with Praluent demonstrating a significant reduction in the relative risk of major adverse CV events (MACE) in patients who had a recent ACS, by 15%.
MACE occurred in 903 patients, which amounts to 9.5% in the Praluent arm and in 1,052 patients, amounting to 11.1% in the placebo arm.
Apart from that, Praluent was associated with a 15% lower risk of death from any cause, which occurred in 334 (3.5%) patients in the Praluent arm and 392 (4.1%) patients in the placebo arm.
George D. Yancopoulos – President and Chief Scientific Officer of Regeneron, on the new EC approval of Praluent, said: “Despite treatment with the current standard of care, including statins, many Europeans with established cardiovascular disease are still unable to control their cholesterol.
“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”.
Praluent prevents the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to the LDL receptor and as a result boosts the number of available LDL receptors on the surface of liver cells to clear LDL, which reduces LDL-C levels in the blood. The CSK9 inhibitor, under a global collaboration agreement, was developed by Regeneron and Sanofi.
Praluent is approved in 60 plus countries, including the US, European Union (EU), Japan, Canada, Switzerland, Brazil and Mexico.
In the EU, Praluent has the approval to be used to lower CV risk in adults with established ASCVD by reducing LDL-C, as an adjunct to correction of other risk factors.
John Reed – Global Head of Research & Development, Sanofi said: “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,” and “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.”