US regulators have approved Amgen’s Repatha as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularisations in adults with cardiovascular disease.
The regulator has expanded the drug’s use on the back of data from the 27,564-patient cardiovascular outcomes study FOURIER, which showed that Repatha (evolocumab) reduced the risk of heart attack by 27 percent, the risk of stroke by 21 percent and the risk of coronary revascularisation by 22 percent.
"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,” said Sean Harper, executive vice president of R&D at Amgen.
The FDA also cleared 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 cut low density lipoprotein cholesterol (LDL-C).
Repatha was first approved in the US in 2015 to treat high levels of cholesterol, in addition to diet and maximally-tolerated statin therapy, in adult patients with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, or clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, when necessary.
However, ever since its arrival on the market the monoclonal antibody has come under fire for its high cost, particularly in the US, where its list price is more than $14,000 a year.