Amgen completes enrollment for FOURIER trial of Repatha (evolocumab)in combination with a statin for reduction of CV risk.

Amgen has 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.

FOURIER, a Phase III 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.

Comment: Repatha is filed at the FDA and in Japan and is CHMP recommended for treatment of adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet. In addition, in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. It is also recommended for the treatment of adults and adolescents aged 12 years and over with homozygous familial hypercholesterolemia (HoFH) in combination with other lipid-lowering therapies.

Comment:

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of 27 August 2015 for the Repatha Biologics License Application (BLA).