FDA approval for Amgen’s Repatha

FDA approval for Amgen’s Repatha
Credit: Amgen

The US Food and Drug Administration has approved Repatha to prevent heart attack and stroke, according to Amgen.

The approval, which follows priority review of Amgen’s supplemental Biologics License Application, sees Repatha become the first PCSK9 inhibitor approved to reduce risk of heart attack, stroke and coronary revascularisation.

“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,” said Sean E. Harper, Executive Vice President of Research and Development at Amgen.

In the Repatha cardiovascular outcomes study (FOURIER), it reduced the risk of heart attack by 27%, the risk of stroke by 21% and the risk of coronary revascularization by 22%.

Anthony C. Hooper, Executive Vice President of Global Commercial Operations at Amgen, said: “In the US, 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.”

The FDA also approved Repatha to be used as an adjunct to diet, alone or in combination with other lipid-lowering therapies, such as statins, for the treatment of adults with primary hyperlipidemia to reduce low density lipoprotein cholesterol (LDL-C).