Amgen announces PCSK9 inhibitor reduces risk of cardiovascular events
Amgen announced on Feb. 2 top-line results of a study that found patients with atherosclerotic cardiovascular disease who received evolocumab (Repatha) had a reduced risk of cardiovascular events, which was the trial’s primary endpoint.
The full results of the FOURIER trial will be presented during a late-breaking clinical trials session at the American College of Cardiology’s annual scientific session in Washington, D.C. on March 17.
As of noon Eastern Standard Time on Feb. 3, Amgen’s stock had increased nearly 4 percent to $165.62 per share since the announcement, which came after markets closed on Feb. 2.
The FDA approved evolocumab in August 2015 for adults with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein (LDL) cholesterol. The injectable drug is part of a class of medications known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.
The approval of evolocumab was based on results from the LAPLACE-2 study, which found that patients who took the drug had a mean 60 percent reduction in LDL cholesterol compared with a placebo group. However, the FDA mandated that Amgen conduct trials evaluating evolocumab’s affect on cardiovascular morbidity and mortality, which had not been established.
The FOURIER trial enrolled approximately 27,500 patients who had an MI, ischemic stroke or symptomatic peripheral artery disease and an LDL cholesterol level of 70 mg/dL or higher or a non-high-density lipoprotein cholesterol level of 100 mg/dL or higher when taking optimized statin therapy. The patients were randomized to receive 140 mg of evolocumab every two weeks, 420 mg of evolocumab once per month or placebo every two weeks or monthly.
The primary composite endpoint was the time to cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or coronary revascularization, while the key secondary endpoint was the time to cardiovascular death, non-fatal MI or non-fatal stroke.
Amgen said the trial met the key secondary endpoint and that the researchers observed no new safety issues.
The company also announced that the EBBINGHAUS trial conducted in patients from the FOURIER trial had met its primary endpoint and demonstrated that patients in the evolocumab group and placebo group had similar cognitive functioning.
For the fourth quarter of 2016, Amgen reported $58 million in sales of evolocumab, including $36 million in the U.S. During the fourth quarter of 2015, the company had $7 million in evolocumab sales, all in the U.S.
For fiscal year 2016, worldwide sales of evolocumab reached $141 million, including $101 million in the U.S., up from $10 million in 2015.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.