Repatha Reduced LDL-C by up to 75 Per Cent Compared With Placebo
First in a New Class of Cholesterol-Lowering Drugs Offers Canadian Physicians and Patients a New Choice in Cholesterol Management
MISSISSAUGA, ON, Sept. 15, 2015 /CNW/ - Amgen Canada Inc. today announced that Health Canada has approved a new cholesterol-lowering medication, RepathaTM (evolocumab). Repatha is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood.1 Repatha is indicated 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 and over with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C. The effect of Repatha on cardiovascular morbidity and mortality has not been determined.2
Elevated LDL-C is an abnormality of cholesterol and/or fats in the blood.3,4 Elevated LDL-C is recognized as a major risk factor for cardiovascular disease,5,6Canada's second leading killer.7 Canadians with clinical atherosclerotic CVD and/or familial hypercholesterolemia (FH) are considered at high risk of cardiovascular disease8,9 and lipid monitoring is important.9,10 About 40 per cent of Canadians have high cholesterol,10 and of patients who are considered at high risk for heart disease, 45 per cent are not meeting their target LDL-C levels.11
FH is an inherited condition caused by genetic mutations which lead to high levels of LDL-C at an early age,12 and it is estimated that less than one per cent of people with FH (heterozygous and homozygous forms) in Canada are diagnosed.13 HeFH prevalence in Canada is highest in Quebec affecting up to one in 270 people.9
In Phase 3 trials, adding Repatha to background lipid-lowering therapy that included statins resulted in consistent reductions in LDL-C levels with favourable effects on other lipid parameters. In patients with clinical atherosclerotic CVD or HeFH, Repatha reduced LDL-C by up to 75 per cent compared with placebo.2 In patients with HoFH, Repatha reduced LDL-C by approximately 32 per cent compared with placebo.2
"Repatha offers a new treatment option for patients who have elevated levels of cholesterol, despite using other lipid-lowering therapies, said Clive Ward-Able, Executive Director, Research and Development, Amgen Canada Inc. "This approval is an important step forward for Canadian patients for the treatment of high cholesterol levels, and marks a significant milestone for Amgen in our ongoing commitment to research in cardiovascular disease."
"The approval of Repatha is an important development in the care of patients at high risk of cardiovascular disease who require additional LDL cholesterol lowering," said Dr. G. B. John Mancini, Professor of Medicine at the University of British Columbia. "Improving the management of cholesterol for these patients is a serious concern for cardiologists, so this new option is welcome."
Patients with genetically high cholesterol can have either one of two types of FH.12 HeFH is the more common type of FH and occurs in approximately one in 500 Canadians.9 It can cause LDL-C levels twice as high as normal (e.g., >4.9 mmol/L).14 Individuals with HeFH have one altered copy of a cholesterol-regulating gene.14 HoFH is the rare, more severe form, in which an individual has two altered copies of cholesterol-regulating genes (one from each parent).12 It can cause LDL-C levels more than six times as high as normal (e.g., >13 mmol/L).15 HoFH is rare, occurring in approximately one in a million individuals.9 The frequency of HoFH is higher in founder populations, such as French Canadians9 in Quebec where the prevalence is approximately one in 275,000.16
About RepathaTM (evolocumab)
Repatha (evolocumab) is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).1 Repatha binds with high affinity 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.2
Important Safety Information2
Repatha is contraindicated in patients who are hypersensitive to Repatha or to any ingredient in the formulation or component of the container. Hypersensitivity reactions (e.g. rash, urticaria) have been reported in patients treated with Repatha, including some that led to discontinuation of therapy. If signs or symptoms of serious allergic reactions occur, discontinue treatment with Repatha, treat according to the standard of care, and monitor until signs and symptoms resolve.
The safety of Repatha was evaluated in approximately 6,700 patients with primary hyperlipidemia and mixed dyslipidemia. The most common adverse reactions of Repatha-treated patients were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, arthralgia and nausea.
In a 52-week trial, the overall incidence of treatment emergent adverse events was comparable between the evolocumab QM (74.8%) and placebo (74.2%) treatment groups.
More information on Adverse Reactions may be found in the Repatha Product Monograph.
About PROFICIO: RepathaTM (evolocumab) Clinical Trial Program
PROFICIO, which stands for the Program to Reduce LDL-C and Cardiovascular Outcomes Following Inhibition of PCSK9 In Different POpulations, is a large and comprehensive clinical trial program evaluating Repatha in 22 clinical trials, with a combined planned enrollment of approximately 35,000 patients.
The Phase 3 program includes 16 trials to evaluate Repatha administered every two weeks and monthly in multiple patient populations, including in combination with statins in patients with hyperlipidemia (LAPLACE-2 and YUKAWA-2); in patients with hyperlipidemia who cannot tolerate statins (GAUSS-2 and GAUSS-3); as a stand-alone treatment in patients with hyperlipidemia (MENDEL-2); in patients whose elevated cholesterol is caused by genetic disorders called heterozygous (RUTHERFORD-2 and TAUSSIG) and homozygous (TESLA and TAUSSIG) familial hypercholesterolemia; the effects of Repatha on lipoprotein metabolism (FLOREY); and the administration of Repatha in statin-treated hyperlipidemic patients (THOMAS-1 and THOMAS-2).
Five ongoing studies in the Repatha Phase 3 program will further provide long-term safety and efficacy data. These include FOURIER (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), which will assess whether treatment with Repatha in combination with statin therapy compared to placebo plus statin therapy reduces recurrent cardiovascular events in approximately 27,500 patients with cardiovascular disease; EBBINGHAUS (Evaluating PCSK9 Binding AntiBody Influence oN CoGnitive HeAlth in High CardiovascUlar Risk Subjects), which will evaluate the effect of Repatha on cognitive function in a subset of patients enrolled in FOURIER; OSLER-2 (Open Label Study of Long TERm Evaluation Against LDL-C Trial-2) in patients with high cholesterol who completed any of the Phase 3 studies; GLAGOV (GLobal Assessment of Plaque ReGression with a PCSK9 AntibOdy as Measured by IntraVascular Ultrasound), which will determine the effect of Repatha on coronary atherosclerosis in approximately 950 patients undergoing cardiac catheterization; and TAUSSIG (Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects with Genetic LDL Disorders), which will assess the long-term safety and efficacy of Repatha on LDL-C in patients with severe familial hypercholesterolemia including patients with homozygous familial hypercholesterolemia. The DESCARTES (Durable Effect of PCSK9 Antibody CompARed wiTh PlacEbo Study) study, a long-term safety and efficacy trial in patients with hyperlipidemia at risk for cardiovascular disease, has completed.
About Amgen Cardiovascular
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.17 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 pipeline consisting of several 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
As a leader in innovation, Amgen Canada understands the value of science. 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. The company contributes to the development of new therapies and new uses for existing medicines in partnership with many of Canada's leading health-care, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca.
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SOURCE Amgen Canada
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