Evolocumab Gains Expanded Indication for Primary Prevention

The US Food and Drug Administration has expanded the indication for evolocumab (Repatha) to include a wider swath of patients at high risk for cardiovascular disease due to elevated LDL cholesterol levels, manufacturer Amgen announced Monday.

The PCSK9 inhibitor is now approved in high-risk adults without established disease to reduce the risk of major cardiovascular events (cardiovascular mortality, MI, stroke, unstable angina requiring hospitalization, or coronary revascularization). Prior to the expanded indication, evolocumab only had the FDA’s signoff for reducing the risk of CVD events (MI, stroke, and revascularization) in patients with established cardiovascular disease.

Evolocumab was approved in 2015 on the basis of its ability to lower LD-cholesterol levels but gained its initial indication for reducing cardiovascular events based on data from the FOURIER trial. In that study of patients with stable atherosclerotic cardiovascular disease, adding evolocumab to usual care reduced the risk of MACE by 15% compared with placebo.

A large study testing evolocumab in primary prevention is still ongoing. In VESALIUS-CV, investigators are randomizing roughly 12,000 patients with high cardiovascular risk but without a prior ischemic event to evolocumab plus usual care or usual care alone.

At the moment, evolocumab is the lone PCSK9 inhibitor approved for reducing MACE in patients without cardiovascular disease. Alirocumab (Praluent; Sanofi/Regeneron) is indicated for reducing MACE in patients with established disease as well as for lowering LDL levels in adults with hypercholesterolemia.