Amgen today announced the completion of patient enrollment in the FOURIER outcomes trial designed to evaluate whether treatment with Repatha (evolocumab) in combination with statin therapy compared to placebo plus statin therapy reduces the risk of recurrent cardiovascular events in patients with high cholesterol and clinically evident cardiovascular disease. Results from the approximately 27,500-patient FOURIER study are expected no later than 2017.
Repatha is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood.1 ¬
“We are pleased to announce that we have completed full enrollment in our cardiovascular outcomes trial, FOURIER, which was designed to investigate whether there is a substantial reduction in the occurrence of major cardiovascular events with the use of Repatha,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We look forward to the results from this important outcomes study for patients with clinically evident cardiovascular disease and high cholesterol.”
FOURIER, a Phase 3 randomized, multicenter, double-blind, placebo-controlled trial, is designed to evaluate whether treatment with Repatha in combination with statin therapy compared to placebo plus statin therapy reduces recurrent cardiovascular events. The primary endpoint in the study is the time to cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke or coronary revascularization. Secondary endpoints include time to cardiovascular death, myocardial infarction or stroke; time to death by any cause; time to cardiovascular death or hospitalization for worsening heart failure; and time to ischemic fatal or non-fatal stroke or transient ischemic attack.
Eligible patients with high cholesterol (LDL-C ≥70 mg/dL or non-high-density lipoprotein cholesterol [non-HDL-C] ≥100 mg/dL) and clinically evident cardiovascular disease at more than 1,200 study locations around the world were randomized to receive subcutaneous Repatha 140 mg every two weeks or 420 mg monthly plus effective statin dose; or subcutaneous placebo every two weeks or monthly plus effective statin dose. Effective statin dose is defined as greater than or equal to atorvastatin 20 mg or an equivalent statin.
“High cholesterol is an important modifiable risk factor for coronary heart disease and stroke,” said Marc S. Sabatine, M.D., M.P.H., co-chairman of the FOURIER executive committee, chairman of TIMI Study Group, senior physician in the Division of Cardiovascular Medicine, Brigham and Women’s Hospital, and professor of medicine at Harvard Medical School, Boston. “We are eager to see if evolocumab will reduce the rate of cardiovascular events in patients at high risk for another event when it is added to standard of care.”
The U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of Aug. 27, 2015, for the Repatha Biologics License Application (BLA).
Additional information on the FOURIER trial and other Repatha clinical studies can be found at www.clinicaltrials.gov
Filed Under: Drug Discovery