FDA OKs Evolocumab for Prevention of Cardiovascular Events

The FDA extended the approval of evolocumab (Repatha, Amgen) to include the prevention of heart attacks, strokes, and coronary revascularizations in adults with established heart disease, according to a company statement. Evolocumab is the first PCSK9 inhibitor to receive this indication.

Evolocumab is also approved as a monotherapy or in addition to other lipid-lowering drugs to reduce low-density lipoprotein cholesterol among adults with primary hyperlipidemia as an adjunct to diet, according to Amgen.

"We are pleased that the FDA made the inclusion of our outcomes data a priority so that patients can benefit from Repatha's ability to reduce life-changing events of heart attacks and strokes," said Sean E. Harper, MD, executive vice president of Research and Development at Amgen. "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."

The approval is based on data from the Repatha cardiovascular outcomes study (FOURIER). In the FOURIER clinical trial, evolocumab demonstrated significant benefits for 27,564 patients with established cardiovascular disease, according to Amgen.

The researchers found that evolocumab lowered the risk of heart attack by 27%, the risk of stroke by 21%, and the risk of coronary revascularization by 22%, according to the release.

Currently, Amgen helps patients gain access to financial assistance, insurance support, and injection training through their RepathaReady program. Patients may also be able to start therapy with evolocumab free of cost through the manufacturer, according to the release.

"In the US, every 40 seconds someone has a heart attack or stroke, and nearly 1 in 3 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," said Anthony C. Hooper, executive vice president of Global Commercial Operations at Amgen. “We will continue to work with payers to help ensure the patients who need Repatha the most are able to get this innovative medicine.”

This article originally appeared on Specialty Pharmacy Times.

Reference

FDA Approves Amgen's Repatha® (evolocumab) To Prevent Heart Attack And Stroke [news release]. Amgen's website. http://www.amgen.com/media/news-releases/2017/12/fda-approves-amgens-repatha-evolocumab-to-prevent-heart-attack-and-stroke/. Accessed December 4, 2017.