Amgen cholesterol drug Repatha bags FDA approval for preventing heart attack and stroke
Repatha FDA approval news : Repatha (evolocumab), the Amgen cholesterol drug has bagged the approval from the US Food and Drug Administration (FDA) for the prevention of heart attacks, strokes and coronary revascularizations in heart disease patients.
The Amgen cholesterol injection is a human monoclonal antibody which has been designed to block the activities of proprotein convertase subtilisin/kexin type 9 (PCSK9).
Repatha FDA approval means that it is the first PCSK9 inhibitor to be okayed by the US drug regulator for the said indications in adults.
Repatha injection was previously approved by the FDA as an adjunct to diet, alone or combined with lipid-lowering therapies such as statins for the treatment of primary hyperlipidemia to bring down the levels of their low density lipoprotein cholesterol (LDL-C).
Commenting on Repatha FDA approval, Sean Harper – Executive Vice President of Amgen Research and Development, 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.”
The Amgen cholesterol injection demonstrated its efficacy in FOURIER, a phase 3 trial featuring 27,564 patients. Repatha injection was successful in the trial by reducing the risk of heart attack by 27%, 21% when it came to risk of stroke and 22% for bringing down the risk of coronary revascularization.
The objective of the placebo-controlled FOURIER trial was to check whether Repatha combined with high- or moderate-intensity statin therapy could cut down cardiovascular events as against placebo plus statin therapy.
Anthony Hooper – Executive Vice President of Amgen Global Commercial Operations, commenting on Repatha FDA approval, 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.”