Repatha: Additional Ph III FOURIER data

Additional data from the double-blind, international Phase III FOURIER trial in 27,564 patients on optimized statin therapy who had either an MI, ischemic stroke or symptomatic peripheral artery disease (PAD) and dyslipidemia showed that subcutaneous Repatha led to an incidence of a composite of CV death, MI, stroke, hospitalization for unstable angina or coronary revascularization, the primary endpoint, of 9.8% vs. 11.3% for placebo (HR=0.85, 95% CI: 0.79, 0.92, p<0.001). Repatha also met the secondary endpoint of reducing the proportion of patients experiencing a composite of CV death, MI or stroke vs. placebo (5.9% vs. 7.4%, HR=0.8, 95% CI: 0.73, 0.88, p<0.001). Additionally, Repatha met the secondary endpoints of reducing the proportion of patients experiencing an MI (3.4% vs. 4.6%, HR=0.73, 95% CI: 0.65, 0.82, p<0.001), stroke (1.5% vs. 1.9%, HR=0.79, 95% CI: 0.66, 0.95, p=0.01), coronary revascularization (5.5% vs. 7%, HR=0.78, 95% CI: 0.71, 0.86, p<0.001), ischemic stroke or transient ischemic attack (1.7% vs. 2.1%, HR=0.77, 95% CI: 0.65, 0.92, p=0.003) and a composite of coronary heart death, non-fatal MI, stroke or coronary revascularization (9.2% vs. 11%, HR=0.83, 95% CI: 0.77, 0.9, p<0.001) vs. placebo.

Repatha missed the secondary endpoints of reducing the proportion of patients experiencing CV death (1.8% vs. 1.7%, HR=1.05, 95% CI: 0.88, 1.25, p=0.62), all-cause death (3.2% vs. 3.1%, HR=1.04, 95% CI: 0.91, 1.19, p=0.54), hospitalization due to unstable angina (1.7% vs. 1.7%, HR=0.99, 95% CI: 0.82, 1.18, p=0.89) and a composite of CV death or hospitalization due to worsening heart failure (2.9% vs. 3%, HR=0.98, 95% CI: 0.86, 1.13, p=0.82) vs. placebo. Patients received placebo or 140 mg Repatha every 2 weeks or 420 mg Repatha once monthly. Data were presented at the American College of Cardiology meeting in Washington, D.C. and published in The New England Journal of Medicine. Amgen previously reported that Repatha met the primary endpoint (see BioCentury, Feb. 10)...