Amgen Canada Release: New Study Results Show Cholesterol-Lowering Medication, Repatha (Evolocumab), Lowers LDL-C When Self-Administered In At-Home Setting

Patients experienced approximately 65 per cent reduction in LDL-C from baseline to end of study

Please note: This information is for Canadian media only

MISSISSAUGA, ON, May 24, 2016 /CNW/ - Amgen Canada Inc. today announced new results from the THOMAS-1 and THOMAS-2 studies, which found that after appropriate training, patients with hypercholesterolemia or mixed dyslipidemia on a statin therapy, with/without ezetimibe were successful in self-administering Repatha (evolocumab) in the at-home setting in approximately 95 per cent of attempts. Rates of successful self-administration were similar regardless of the patients' dosing schedule or injection device (autoinjector, pre-filled syringe or automated minidoser). The study also showed that the bi-weekly and monthly dosing regimens provided similar low-density lipoprotein cholesterol (LDL-C) reductions of approximately 65 per cent from baseline to end of study. The LDL-C reductions were comparable across dosing regimens and devices and consistent with expectations from the other Repatha clinical studies.¹

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 LDL-C, or "bad" cholesterol, from the blood.² 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.³

"The results of the THOMAS studies mark an advance in the treatment of dyslipidemia with an injectable lipid therapy in the at-home setting," says Dr. Robert Hegele, Lipid Clinic Director, London Health Sciences Centre, and Professor, Department of Medicine, Western University. "While injectable biologics for home-use are available for several other conditions, injectable therapies, like Repatha, are quite new for the treatment of dyslipidemia. That makes these positive study results clinically relevant. In addition, the LDL-C reductions observed in the THOMAS studies were consistent with previously reported Repatha studies."

Adverse events (AEs) in the THOMAS studies were of low frequency and severity and were similar between groups (25.6 32.9 per cent for AEs, 0-1.4 per cent for serious AEs).  The most commonly occurring AEs in THOMAS-1 were headache (4 per cent), bronchitis (2 per cent) and abdominal pain (2 per cent).  The most commonly occurring AEs in THOMAS-2 were pain in the extremity, fatigue and sinusitis (all 2 per cent).¹

Elevated LDL-C is an abnormality of cholesterol and/or fats in the blood.^4,5 Elevated LDL-C is recognized as a major risk factor for cardiovascular disease,^6,7Canada's second leading killer.⁸ Canadians with clinical atherosclerotic CVD and/or familial hypercholesterolemia (FH) are considered at high risk of cardiovascular disease^9,10 and lipid monitoring is important.^10,11 About 40 per cent of Canadians have high cholesterol,¹¹ and of patients who are considered at high risk for heart disease, 45 per cent are not meeting their target LDL-C levels.¹²

FH is an inherited condition caused by genetic mutations which lead to high levels of LDL-C at an early age¹³, and it is estimated that less than one per cent of people with FH (heterozygous and homozygous forms) in Canada are diagnosed.¹⁴ HeFH prevalence in Canada is highest in Quebec affecting up to one in 270 people.¹⁰

About Repatha^TM (evolocumab)
Repatha (evolocumab) is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).² 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.³

Important Safety Information³
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 THOMAS-1 and THOMAS-2¹
THOMAS-1 and THOMAS-2 were multicenter, open label, parallel-arm, randomized studies that enrolled patients at 22 and 23 sites (respectively) in the United States and Canada. Patients with hypercholesterolemia or mixed dyslipidemia on statin therapy with or without ezetimibe were eligible. Enrolled patients were randomized to receive evolocumab administered at home with the pre-filled SureClick^® autoinjector versus a pre-filled syringe (PFS) (THOMAS-1) or the pre-filled SureClick^® autoinjector versus an on-body electromechanical injection device: automated minidoser. The primary endpoint of both THOMAS studies was the patient-reported successful outcome of attempted self-administered full-dose of Repatha in the home-use setting with the injection device. The secondary endpoint was the mean change in LDL-C from baseline to 6 weeks in THOMAS-1 and the mean of weeks 10 and 12 in THOMAS-2.

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.¹⁵ 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.

Forward-Looking Statements
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References

SOURCE Amgen Canada