New Indication Supports Amgen’s Commitment to Reduce the Risk of Recurrent Cardiovascular Events Faced by Heart Attack and Stroke Survivors
MISSISSAUGA, ON (June 19, 2018) – Today Amgen Canada announced that Health Canada has now indicated Repatha as an adjunct to diet and standard of care therapy (including moderate- to high-intensity statin therapy alone or in combination with other lipid-lowering therapy), to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adult patients with atherosclerotic cardiovascular disease.1
Of all the modifiable risk factors for heart attack and stroke, lowering high low-density lipoprotein cholesterol (LDL-C) is one of the most important and impactful.2,3 Yet, even among patients currently taking a lipid-lowering therapy, many patients still have high LDL-C levels and remain at risk for cardiovascular events. Patients with a previous history of cardiovascular events are at an increased risk of subsequent events, especially in the first year.4 Repatha has been demonstrated to effectively lower “bad cholesterol” or LDL-C for high-risk patients who suffer from a combination of high LDL-C and cardiovascular disease, and who continue to struggle with lowering their LDL-C levels despite statin therapy.
“Heart disease is the second leading cause of death among Canadians and is one of the main reasons for hospitalizations and disability in Canada,”5 said Ponda Motsepe-Ditshego, Executive Medical Director at Amgen Canada. “We are pleased that Health Canada reviewed and included the Repatha cardiovascular outcomes study (FOURIER) data in the product indication. This updated indication provides a new option for physicians to prevent cardiovascular events in patients who have elevated levels of cholesterol, despite being treated optimally with other lipid-lowering therapies, and who may benefit from Repatha’s ability to reduce heart attacks and strokes by lowering LDL cholesterol.”
In the Repatha cardiovascular outcomes study (FOURIER), Repatha reduced the risk of heart attack by 27 per cent, the risk of stroke by 21 per cent, and the risk of coronary revascularization by 22 per cent.6
"Despite advances and efforts over over the past 25 years, many of our high-risk patients are still not at recommended Canadian guideline targets (DYSIS),"7 said Dr. Lawrence Leiter, Canadian Lead Investigator for the Repatha cardiovascular outcomes study (FOURIER) trial and Director of the Lipid Clinic at St. Michael’s Hospital in Toronto. “With this additional clinical evidence, physicians and their appropriate patients now have another effective option to help further lower the LDL ("bad") cholesterol and reduce the risk of heart attacks and strokes.”
Health Canada previously indicated Repatha as an adjunct to diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies in adults and adolescent patients aged 12 years and over with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C.1
Repatha Cardiovascular Outcomes (FOURIER) Study Design
FOURIER (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), a multinational Phase 3 randomized, double-blind, placebo-controlled trial, was designed to evaluate whether treatment with Repatha in combination with statin therapy compared to placebo plus statin therapy reduces cardiovascular events. The primary endpoint was the time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary endpoint was the time to cardiovascular death, myocardial infarction or stroke.
Eligible patients with high cholesterol (LDL-C ≥1.8 mmol/L or non-high-density lipoprotein cholesterol [non-HDL-C] ≥2.6 mmol/L) and clinically evident atherosclerotic cardiovascular disease at more than 1,200 study locations around the world, including Canada, were randomized to receive Repatha subcutaneous 140 mg every two weeks or 420 mg monthly plus optimized statin dose; or placebo subcutaneous every two weeks or monthly plus effective statin dose. Effective statin therapy was defined as at least atorvastatin 20 mg or equivalent daily with a recommendation for at least atorvastatin 40 mg or equivalent daily where approved. The study was event driven and continued until at least 1,630 patients experienced a key secondary endpoint.
About Repatha® (evolocumab)1
Repatha (evolocumab) is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds selectively and with high affinity to PCSK9, and inhibits circulating PCSK9 from binding to the LDLR on the liver cell surface, thus preventing PCSK9-mediated LDLR degradation therefore increasing the number of LDLR available to clear LDL, thereby lowering serum LDL-C levels.
Repatha is indicated as an adjunct to diet and standard of care therapy (including moderate- to high-intensity statin therapy alone or in combination with other lipid-lowering therapy), to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adult patients with atherosclerotic cardiovascular disease.
About Amgen in the Cardiovascular Therapeutic Area
Building on more than three decades of experience in developing biotechnology medicines for patients with serious illnesses, Amgen is dedicated to addressing important scientific questions to advance care and improve the lives of patients with cardiovascular disease, the leading cause of morbidity and mortality worldwide.8 Amgen's research into cardiovascular disease, and potential treatment options, is part of a growing competency at Amgen that utilizes human genetics to identify and validate certain drug targets. Through its own research and development efforts, as well as partnerships, Amgen is building a robust cardiovascular portfolio consisting of several approved and investigational molecules in an effort to address a number of today's important unmet patient needs, such as high cholesterol and heart failure.
About Amgen Canada Inc.
With main operations located in Mississauga, Ont.’s vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. To learn more about Amgen Canada, visit www.amgen.ca.
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