First PCSK9 Inhibitor Gets FDA Approval for MI, Stroke Prevention

Repatha reduced the risk of heart attack by 27%, the risk of stroke by 21% and the risk of coronary revascularization by 22%.

Amgen announced that the Food and Drug Administration (FDA) has approved Repatha (evolocumab) for the prevention of heart attacks, strokes, and coronary revascularizations in adults with established cardiovascular disease. 

Findings from the Phase 3 cardiovascular outcomes study (FOURIER; N=27,564) showed Repatha statistically significantly lowered the risk of heart attack by 27% (P<0.001), stroke by 21% (P=0.01), and coronary revascularization by 22% (P<0.001). No effect on cardiovascular mortality was seen. In addition, Repatha demonstrated a statistically significant 15% reduction (P<0.001) in the risk of the primary composite endpoint, which included hospitalization for unstable angina, coronary revascularization, heart attack, stroke, or cardiovascular death. 

Repatha, a proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor, is already approved as an adjunct to diet and maximally tolerated statin therapy, in adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease requiring additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies, in patients with homozygous familial hypercholesterolemia (HoFH) requiring additional lowering of LDL-C. 

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Repatha is available as a 140mg/mL strength prefilled syringe or SureClick autoinjector for subcutaneous (SC) injection as well as a 420mg/3.5mL strength Repatha Pushtronex system, an on-body infusor with prefilled cartridge.

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