FDA approves evolocumab to prevent heart attack and stroke

The FDA has approved Amgen’s evolocumab (Repatha) for the prevention of strokes, heart attacks and coronary revascularizations—the first PCSK9 inhibitor to gain approval for such a broad number of indications.

The randomized FOURIER trial demonstrated evolocumab—when used in addition to optimized statin therapy—reduced the risk of heart attack by 27 percent, the risk of stroke by 21 percent and the risk of coronary revascularization by 22 percent, according to an Amgen press release. The trial included 27,564 patients with high cholesterol and established cardiovascular disease and a median follow-up period of 2.2 years.

Evolocumab, which lowers low-density lipoprotein (LDL) cholesterol, is approved as a standalone therapy and as an adjunct to other lipid-lowering medications.

"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," Sean E. Harper, MD, executive vice president of research and development at Amgen, said in the release. "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."

Cost appears to be the next hurdle for widespread adoption of evolocumab. One analysis showed the drug would need a 62 percent lower price tag to meet a commonly accepted cost-effectiveness threshold.

“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, Amgen’s executive vice president of global commercial operations. “We will continue to work with payers to help ensure the patients who need Repatha the most are able to get this innovative medicine.”