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Amgen’s Repatha approved by FDA for heart attack and stroke prevention

PBR Staff Writer Published 04 December 2017

Amgen’s cholesterol drug Repatha (evolocumab) has been approved by the US Food and Drug Administration (FDA) to prevent heart attacks, strokes and coronary revascularizations in adults having cardiovascular disease.

A human monoclonal antibody, Repatha has been designed to suppress proprotein convertase subtilisin/kexin type 9 (PCSK9). It is now the first PCSK9 inhibitor to be approved in the US for the indications.

The injectable cholesterol drug has also been approved by the FDA to be used as a supplement to diet, alone or in combination with statins and other lipid-lowering therapies for treating adults with primary hyperlipidemia to lower their low density lipoprotein cholesterol (LDL-C) levels.

Amgen Research and Development executive vice president Sean Harper said: “Despite treatment with current best therapy, many patients are still at high risk for cardiovascular events.

“Physicians now have a new FDA-approved treatment option to prevent cardiovascular events by dramatically lowering LDL cholesterol with Repatha, especially for patients already on maximally-tolerated statin therapy who need further LDL cholesterol lowering.”

In a phase 3 trial named as FOURIER that enrolled 27,564 patients, Repatha was demonstrated to have lowered the risk of heart attack by 27%, the risk of stroke by 21% and the risk of coronary revascularization by 22%.

The placebo-controlled trial assessed if treatment with Repatha in combination with high- or moderate-intensity statin therapy could reduce cardiovascular events in comparison to placebo plus statin therapy.

Amgen Global Commercial Operations executive vice president Anthony Hooper said: “In the U.S., every 40 seconds someone has a heart attack or stroke, and nearly one in three of these patients will have another event, leading to a societal cost that exceeds $600 billion annually.

“With this approval, it's now more important than ever that appropriate patients obtain access to Repatha in order to avoid preventable heart attacks and strokes. We will continue to work with payers to help ensure the patients who need Repatha the most are able to get this innovative medicine.”


Image: Amgen’s Repatha (evolocumab) injection. Photo: courtesy of Amgen.