Health Canada has approved Repatha (evolocumab) for yet another indication – this time 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.
The drug is also approved in Canada for patients with the fairly common condition, primary hyperlipidemiaas well as the extremely rare disease, homozygous familial hypercholesterolemia (HoFH).
Repatha is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) that can dramatically lower LDL-Cholesterol levels.
The approval was largely based on a huge phase 3 clinical trial, published in the New England Journal of Medicine, involving 27,564 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 who were given Repatha (140 mg every 2 weeks or 420 mg monthly)in combination with statin therapy versus those given placebo plus statin therapy.
After 48 weeks of treatment, patients in the Repatha-treated group had significantly lower cholesterol levels compared to the placebo-treated group but more importantly, relative to placebo, Repatha treatment significantly reduced the risk of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. More specifically, 9.8% of patients in the Repatha-treated group had a cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization compared to 11.3% of patients in the placebo-treated group.
Furthermore, Repatha treatment reduced the risk of heart attack by 27%, the risk of stroke by 21%, and the risk of coronary revascularization by 22%, according to Amgen, the makers of Repatha.
In a news release, Ponda Motsepe-Ditshego, MD, Executive Medical Director at Amgen Canada stated “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.”
“Despite advances and efforts over the past 25 years, many of our high-risk patients are still not at recommended Canadian guideline targets (DYSIS),” said Lawrence Leiter, MD, Director of the Lipid Clinic at St. Michael’s Hospital in Toronto, adding, “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.”
Sabatine MS, Giugliano RP, Keech AC, et al, for the FOURIER Steering Committee and Investigators. N Engl J Med.Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. 2017;376:1713-22.doi: 10.1056/NEJMoa1615664