Regeneron Pharmaceuticals and Sanofi have received a significant boost with the European Commission’s (EC) approval of Praluent (alirocumab) for a new indication. The approval enables Praluent to be used as an adjunct treatment to reduce low-density lipoprotein cholesterol (LDL-C) levels in adults with atherosclerotic cardiovascular disease (ASCVD), aiming to lower the risk of further cardiovascular events.

ASCVD is a condition marked by the build-up of plaque in the arteries, leading to restricted blood flow and increasing the risk of severe cardiovascular issues such as stroke, peripheral artery disease, and acute coronary syndrome (ACS), including heart attacks and unstable angina.

European approval based on solid clinical data

The latest EC approval is grounded in the promising results of the ODYSSEY OUTCOMES trial, a phase 3 clinical trial that evaluated the impact of adding Praluent to the maximally tolerated doses of statins. In this large-scale trial, involving 18,924 patients who had suffered an ACS within the previous 1-12 months, Praluent was shown to have a significant impact on cardiovascular risk reduction.

The trial’s primary endpoint was met, as Praluent reduced the relative risk of major adverse cardiovascular events (MACE) by 15% in the patient group that had recently experienced an ACS. Notably, MACE occurred in 9.5% of the patients receiving Praluent, compared to 11.1% in those receiving a placebo. Additionally, Praluent was associated with a 15% reduction in the risk of death from any cause, with 3.5% of patients in the Praluent arm experiencing death, versus 4.1% in the placebo arm.

A breakthrough for European patients

Commenting on the approval, George D. Yancopoulos, President and Chief Scientific Officer of Regeneron, highlighted the significance of this new indication for patients struggling to control cholesterol despite existing treatments, including statins. He stated, “Despite treatment with the current standard of care, including statins, many Europeans with established cardiovascular disease are still unable to control their cholesterol.” He went on to emphasize that Praluent’s efficacy in reducing the risk of heart attack, stroke, and unstable angina, along with lowering death from any cause, provides a much-needed treatment option for these patients.

Praluent, which works by preventing the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to the LDL receptor, thereby increasing the number of receptors available to clear LDL, has already received approval in over 60 countries, including the US, EU, Japan, Canada, and Switzerland. Its new approval in the European Union positions it as an important adjunctive treatment to address ASCVD risk by lowering LDL-C levels.

A treatment option for challenging cases

John Reed, Global Head of Research & Development at Sanofi, noted the significance of this approval for patients who face difficulty in controlling their cholesterol levels despite lifestyle changes and statin therapy. He added, “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.”

As both Regeneron and Sanofi continue their collaboration on Praluent, this approval underscores their commitment to addressing the significant unmet needs of cardiovascular disease patients, particularly those with ASCVD who remain at high risk of further events despite optimal therapy.

This approval could not only expand the market potential for Praluent but also offers patients a new weapon in their fight against cardiovascular risk.

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