FDA OKs Evolocumab Indication for CV Risk Reduction

Laurie Toich, Assistant Editor
Published Online: Monday, December 4th, 2017
The FDA has approved evolocumab (Repatha, Amgen) for the prevention of heart attacks, stroke, and coronary revascularizations in adult patients with already established cardiovascular disease, according to a company press release. 

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. 


Current Issue

The Educated Patient

Sara Marlow, MSN, RN, PHN, FNP-C
Sunburn is still a major health issue that can be prevented.
Kristen Marjama, DNP, FNP-BC
The National Health Interview Survey in 2014 estimated that 17.7 million adults and 6.3 million children had asthma.
Mary McCormack, MSN, APNC, MPH
The World Gastroenterology Organization describes the prevalence of celiac disease as a “statistical iceberg” in today’s health climate.
Melissa DeCapua, DNP, PMHNP-B-C
Diabetic retinopathy causes more losses of vision worldwide than any other eye disease, affecting 33% of the 285 million individuals suffering from diabetes.
$vacMongoViewPlus$ $vAR$
Contemporary Clinic
MJH Associates
American Journal of Managed Care
Cure
MD Magazine
ONCLive
OTCGuide
Pharmacy Times
Specialty Pharmacy Times
Targeted Oncology
About Us
Advertise
Careers
Contact Us
Feedback
Privacy
Terms & Conditions
Pharmacy Healthcare & Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-257-0701

Copyright Contemporary Clinic 2017
Pharmacy Healthcare & Communications, LLC. All Rights Reserved.