Amgen's Repatha was shown to reduce the risk of cardiovascular events, such as cardiovascular death and myocardial infarction, in phase 3 of the FOURIER study. Full results will be presented in March 2017 at the American College of Cardiology 66th Scientific Sessions.
In the FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects With Elevated Risk) study, researchers determined that Repatha (evolocumab) reduced the risk of cardiovascular (CV) events (CV death, non-fatal myocardial infarction [MI], non-fatal stroke, hospitalization for unstable angina, or coronary revascularization) in patients with clinically evident atherosclerotic CV disease who were also being treated with statin therapy.
Repatha is a PCSK9 inhibitor, which has been shown to dramatically reduce low-density lipoprotein (LDL) cholesterol. Recently, a judge ruled that Sanofi and Regeneron must stop selling their rival PCSK9 inhibitor alirocumab (Praluent) because of a patent infringement. However, Sanofi and Regeneron have filed an motion to stay the injunction pending an appeal and Praluent remains on the market.
The FOURIER study was a phase 3 double-blind, randomized, placebo-controlled trial with approximately 27,500 patients who had either a MI, an ischemic stroke, or symptomatic peripheral artery disease, and an LDL of ≥70 mg/dL or a non—high-density lipoprotein cholesterol of ≥100 mg/dL. Patients were on an optimized statin therapy and randomized to receive Repatha at a 140 mg dose every 2 weeks or a 420 mg dose monthly or a placebo every 2 weeks or monthly.
“These FOURIER results show unequivocally the connection between lowering LDL cholesterol with Repatha and cardiovascular risk reduction, even in a population already treated with optimized statin therapy," Sean E. Harper, MD, executive vice president of Research and Development at Amgen, said in a statement.
The primary endpoint was time to CV death, MI, stroke, hospitalization for unstable angina, or coronary revascularization. The study ended when at least 1630 patients experienced a key secondary major adverse cardiac event of CV death, MI, or stroke.
In a previous clinical trial—the GLAGOV study—Amgen had demonstrated that Repatha had an effect on atherosclerosis and was superior to placebo at reducing coronary plaque. Those results had been presented at the American Heart Association Annual Scientific Sessions in November 2016.
The full results of the trial will be presented at the American College of Cardiology (ACC) 66th Scientific Sessions in Washington, DC, March 17-19. The American Journal of Managed Care® will be at ACC, covering sessions and interviewing experts. To sign up for our conference coverage e-mail, click here.
Two years ago at the ACC 64th Scientific Sessions, study findings were presented that showed Repatha reduced the likelihood that patients would die, suffer a heart attack or stroke, or need a procedure to open blocked arteries. At the time, the drug had not yet been approved by the FDA.