For research and educational purposes only. Not medical advice.
Evolocumab Reference
Educational, not medical advice reference for Evolocumab: Metabolic; regulatory status, evidence posture, source review, and schedule notes. Also known as Re…
Reference summary
FOURIER (Sabatine 2017 NEJM, n=27,564) randomized statin-treated patients with established atherosclerotic cardiovascular disease to evolocumab vs placebo over a median 2.2 years. The primary 5-component MACE composite was reduced by 15 percent relative; the harder 3-component cardiovascular-death / MI / stroke composite was reduced by 20 percent. The median LDL-C in the evolocumab arm fell from 92 mg/dL to 30 mg/dL.
Regulatory and posture
- Categories
- Metabolic
- Aliases
- Repatha, AMG 145, Fully human IgG2 PCSK9-targeting monoclonal antibody
- Evidence posture
- human
- Regulatory status
- FDA-approved as Repatha (2015) as an adjunct to diet and maximally tolerated statin therapy for adults and pediatric patients aged 10 and older with HeFH; adjunct to other LDL-lowering therapies in HoFH; and to reduce risk of MI, stroke, and coronary revascularization in adults with established cardiovascular disease.
- Content review status
- label verified