15 September 2015 - Amgen Canada Inc. today announced that Health Canada has approved a new cholesterol-lowering medication, Repatha (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. 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.

Elevated LDL-C is an abnormality of cholesterol and/or fats in the blood. Elevated LDL-C is recognized as a major risk factor for cardiovascular disease, Canada’s second leading killer. 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.

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

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. In patients with HoFH, Repatha reduced LDL-C by approximately 32 per cent compared with placebo.

“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.

For more details, go to: http://www.amgen.ca/english/media/repatha_press_release.html