공시 • Mar 30
Amgen Announces Repatha Cuts Risk Of First Major Cardiovascular Events By 31% In High-Risk Patients Without Known Significant Atherosclerosis
Amgen announced that Repatha (evolocumab), when added to statins or other low-density lipoprotein cholesterol (LDL-C)-lowering treatments, reduced the risk of first major adverse cardiovascular (CV) events (MACE) in high-risk primary prevention patients without known significant atherosclerosis (buildup of plaque in the arteries) and with diabetes. The results are from a new subgroup analysis of 3,655 patients at increased risk of CV events without known significant atherosclerosis (all of whom had diabetes) followed for a median of 4.8 years from the Phase 3 VESALIUS-CV clinical trial. Results showed Repatha reduced the risk of the composite primary endpoint of coronary heart disease (CHD) death, myocardial infarction or ischemic stroke (3-P MACE) by 31% compared with placebo. Repatha also reduced the risk of a dual composite primary endpoint that included ischemia-driven revascularization (4-P MACE) by 31%. The median achieved LDL-C was 44 mg/dL at 96 weeks in the Repatha added to optimized lipid-lowering therapy arm compared to 105 mg/dL in the placebo plus optimized lipid-lowering therapy arm (548 patients in the subgroup were part of a lipid sub-study). Across secondary endpoints, Repatha demonstrated consistent benefit, including the following composite endpoints: heart attack, ischemic stroke or any ischemia-driven revascularization; CHD death, heart attack or revascularization; CV death, heart attack or ischemic stroke. Among individual secondary endpoints, Repatha showed numerical reductions in the risk of heart attack by 31%, ischemia-driven revascularization by 34% and ischemic stroke by 33%. Repatha demonstrated numerical trends for reduced mortality rates, including CV death (32% relative risk reduction), CHD death (27% relative risk reduction) and all-cause death (24% relative risk reduction). VESALIUS-CV is a Phase 3, double-blind, randomized, placebo-controlled, global clinical trial designed to evaluate the impact of LDL-C lowering with evolocumab on MACE in adults at high CV risk without prior heart attack or stroke. Repatha demonstrated a 25% relative reduction in the risk of a composite of coronary heart disease (CHD) death, heart attack or ischemic stroke (3-P MACE), and 19% reduction in a broader composite that also included any ischemia-driven arterial revascularization (4-P MACE). Repatha also reduced the risk of heart attack by 36%. VESALIUS-CV enrolled more than 12,000 patients with known ASCVD or high-risk diabetes, who had no history of heart attack or stroke, an LDL-C = 90 mg/dL, or non-high-density lipoprotein cholesterol (non-HDL-C) = 120 mg/dL, or apolipoprotein B = 80 mg/dL; and treated with highest tolerated dose of statin and/or ezetimibe. The median baseline LDL-C was 122 mg/dL (IQR, 104-149 mg/dL) on local lab testing. Participants were randomized to receive Repatha or placebo in addition to optimized lipid-lowering therapy and were followed for a median of approximately 4.6 years. Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels. Repatha is one of the most extensively studied PCSK9 inhibitors, with clinical and real-world evidence across diverse populations and CV risk profiles. The clinical benefits and safety of Repatha have been studied for 15 years in 51 clinical trials with over 57,000 patients. Repatha is the only PCSK9 inhibitor to demonstrate a significant reduction of cardiovascular events as both high-risk primary and secondary prevention. Repatha has been prescribed to over 8 million patients globally and is approved in 74 countries, including the U.S., Japan, Canada and in all 28 countries that are members of the European Union. Applications in other countries are pending. Repatha is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor indicated to reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH), adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). The safety and effectiveness of Repatha have not been established in pediatric patients with HeFH or HoFH who are younger than 10 years old or in pediatric patients with other types of hypercholesterolemia. Repatha is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha. Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Repatha, treat according to the standard of care, and monitor until signs and symptoms resolve. The most common adverse reactions (>5% of patients treated with Repatha and more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.