FDA approval was granted to Amgen's evolocumb (Repatha) on Friday for the prevention of heart attacks, strokes, and coronary revascularizations in patients with established cardiovascular disease, the drugmaker announced -- making it the only PCSK9 inhibitor green-lighted for such a wide swath of adults.
Used for prevention by lowering low-density lipoprotein (LDL) cholesterol, evolocumab is now approved as an adjunct to other lipid-lowering medications and as a stand-alone therapy.
However, cost is still going to be a problem going forward: one study estimated that the drug's price will need to be slashed by more than 70% in order to be reasonably cost-effective for patients.
"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," said Anthony C. Hooper, executive vice president of Global Commercial Operations at Amgen, in a statement.
Evolocumab was first FDA approved in 2015 for patients with familial hypercholesterolemia and others who fail to achieve LDL cholesterol lowering through diet and maximally-tolerated statin therapy.
The randomized FOURIER trial showed that evolocumab reduced cardiovascular event rates for patients with high cholesterol and established cardiovascular disease.