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Amgen announced the phase 3 VESALIUS-CV clinical trial met its dual primary endpoints demonstrating that Repatha (evolocumab) significantly reduced the risk of major adverse cardiovascular events (MACE) in individuals without a prior history of heart attack or stroke. The landmark phase 3 VESALIUS-CV trial enrolled over 12,000 high-risk patients, approximately 85% of whom were maintained on a high-intensity or moderate low-density lipoprotein cholesterol (LDL-C) reducing therapy. Patients were followed for a median of approximately 4.5 years.
Cardiovascular disease remains the leading cause of death worldwide. In 2017, the FOURIER study proved that Repatha reduced the risk of major cardiovascular (CV) events in people with established atherosclerotic disease (ASCVD) and a history of major cardiovascular events, such as heart attack or stroke. The VESALIUS-CV study was initiated to determine if Repatha could also reduce CV events in people without a history of heart attack or stroke. VESALIUS-CV now establishes that Repatha, added to statins or other LDL-C lowering treatments, significantly reduces cardiovascular events compared with standard therapy alone as primary prevention.
The VESALIUS-CV primary endpoints were time to first occurrence of a composite of coronary heart disease (CHD) death, heart attack or ischemic stroke as well as time to first occurrence of a composite of CHD death, heart attack, ischemic stroke or any ischemia-driven arterial revascularization. The results show that the primary endpoints were both statistically and clinically significant. No new safety signals were observed.
"These results mark an important milestone in the fight against cardiovascular disease, the leading cause of death worldwide. The benefit across endpoints and established safety profile underscore Repatha's role as a cornerstone therapy in comprehensive lipid management," said Jay Bradner, M.D., executive vice president of research and development at Amgen. "Repatha is known as a highly effective LDL-C lowering treatment and is now the first and only PCSK9 inhibitor shown to reduce cardiovascular events in high-risk adults without prior heart attack or stroke. These additional data demonstrate that Repatha has the potential to reach tens of millions more patients earlier in their journey, before a life-altering event occurs."
Full results from the trial will be presented at the American Heart Association Scientific Sessions on Nov. 8 as part of the session "Groundbreaking Trials in Cardiometabolic Therapeutics," and will be submitted for publication in a peer-reviewed journal.
Every 40 seconds, a heart attack or stroke occurs in the US, and 75% of those are first-time events. High LDL-C, or "bad" cholesterol, is one of the most modifiable risk factors for heart attack and stroke. However, more than 80% of patients with high CV risk without a prior heart attack or stroke were not at recommended LDL-C levels of lower than 70 mg/dL after one year of follow up, according to a recent study.
Repatha was first approved in 2015 and has since been used by more than 6.7 million patients globally. Repatha is the most extensively studied PCSK9 inhibitor, with clinical and real-world evidence across diverse populations and CV risk profiles.
Earlier this year, the US Food and Drug Administration broadened the approved use of Repatha to include adults at increased risk for major adverse CV events due to uncontrolled LDL-C.
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.
VESALIUS-CV enrolled more than 12,000 patients with known atherosclerotic cardiovascular disease (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 optimized lipid-lowering therapy. Participants were randomized to receive Repatha or placebo in addition to optimized lipid-lowering therapy and were followed for a median of approximately 4.5 years.
Cardiovascular disease (CVD) remains a major global health threat, linked to multiple interrelated risk factors like high LDL-C, Lp(a), obesity, diabetes and hypertension. These risks often coexist and require a comprehensive approach to prevention and care. Amgen is taking bold action, building on decades of leadership in CVD through LDL-C management to advance additional innovative, investigational treatments in the pipeline targeting common drivers of CVD. By combining scientific innovation with strategic partnerships to drive earlier testing, better care and broader access, Amgen's efforts reflect a sustained commitment to advancing both the science and the system of CV care.
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.
The clinical benefits and safety of Repatha have been studied for 15 years in 51 clinical trials with over 57,000 patients. Repatha is approved in 74 countries, including the US, 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 paediatric patients with other types of hyperlipidemia.
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