- Approval is based on ODYSSEY OUTCOMES trial of 18,924 patients who recently suffered an acute coronary syndrome such as a heart attack
- Praluent is the only EU-approved PCSK9 inhibitor with cardiovascular outcomes data that showed an association with reduced death from any cause
PARIS and TARRYTOWN, NY – March 15, 2019 – 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.
“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,” said John Reed, M.D., Ph.D., Global Head of Research & Development, Sanofi. “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.
“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.
“Despite treatment with the current standard of care including statins, many Europeans with established cardiovascular disease are still unable to control their cholesterol,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer, 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.”
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%).
Praluent is the only PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor available in two starting doses as a single 1 milliliter (mL) injection (75 mg and 150 mg) once every two weeks and can also be administered as 300 mg once every four weeks (monthly), enabling physicians to tailor treatment based on an individual patient’s LDL-C-lowering needs. Data from ODYSSEY OUTCOMES have also been submitted to the U.S. Food and Drug Administration (FDA), with a target action date of April 28, 2019.