Repatha Reduces Cardiovascular Risk, Amgen Says

In a press release, Amgen, Inc. announced early results of the FOURIER trial stating that the trial met its primary composite endpoint showing that Repatha (evolocumab, Amgen, Inc.) reduces the risk of cardiovascular events in patients with clinically evident atherosclerotic cardiovascular disease.

The phase 3, multinational, FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) trial was undertaken to assess whether combining Repatha with statins reduces cardiovascular events when compared to combination placebo and statins.

The trial includes about 27,500 patients with cardiovascular disease randomized to subcutaneous evolocumab 140 mg every 2 weeks or 420 mg monthly or to placebo. All patients either had a myocardial infarction, ischemic stroke, or symptomatic peripheral artery disease, and a low-density lipoprotein (LDL) >70 mg/dL or a non-high-density lipoprotein cholesterol >100 mg/dL while on optimized statin therapy.

Details of the results will be presented during the upcoming American College of Cardiology (ACC) meeting in mid-March.

Reporting for Health News, Bill Berkrot said that the positive results of the trial were expected and suggested that the real news will be what is learned during the ACC presentation when details of the magnitude of the benefit of Repatha is revealed.

“Industry analysts have been looking for a 15 percent to 20 percent reduction of major adverse heart events,” Berkrot writes, saying that “Repatha, with a list price of more than $14,000 a year, was approved based on its ability to dramatically lower ‘bad’ LDL cholesterol in patients who require more intensive therapy on top of widely-used statins, such as Lipitor, or who are unable to tolerate statins.” —Mary Beth Nierengarten