Evolocumab Wins for Primary Prevention in VESALIUS-CV

When added to statins or other cholesterol-lowering agents, the PCSK9 inhibitor evolocumab (Repatha) reduces the risk of MACE better than standard therapy alone in individuals with no prior history of CV events, according to top-line results of the VESALIUS-CV trial announced by drugmaker Amgen.

The phase III trial of more than 12,000 high-risk patients randomized to the subcutaneously injected PCSK9 inhibitor or placebo and followed for a median of 4.5 years met its primary endpoints: time to first occurrence of a composite of coronary heart disease (CHD) death, MI, or ischemic stroke and of a composite of CHD death, MI, ischemic stroke, or any ischemia-driven revascularization.

The news comes a few weeks after the US Food and Drug Administration expanded the indication for evolocumab to include primary prevention in high-risk adults without established CV disease to reduce the risk of major CV events. The drug was initially approved in 2015 on the basis of its ability to lower LDL cholesterol, but gained its initial indication for reducing CV events based on data from the FOURIER trial. Evolocumab is currently the only PCSK9 inhibitor approved for reducing MACE risk in those without CV disease.

Full results of VESALIUS-CV are scheduled for presentation at the upcoming American Heart Association Scientific Sessions, and Amgen says they also will be submitted for publication in a peer-reviewed journal.