Regulatory Decision Summary for REPATHA
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
This Supplement to a New Drug Submission (SNDS) was filed to obtain market authorization for Repatha to reduce the risk of major adverse cardiovascular events. Upon review, the following indication was approved: 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.
Why was the decision issued?
The safety and efficacy of Repatha were evaluated in a randomized, double-blind, placebo-controlled Phase 3 clinical trial of patients with established atherosclerotic cardiovascular disease. Repatha treatment, in addition to standard of clinical care (including dietary advice and moderate- to high-intensity statin therapy), significantly reduced the risk of myocardial infarction, stroke, and coronary revascularization compared to placebo. The safety profile of Repatha in this patient population was similar to that observed in previous studies of Repatha. The effects of Repatha in patients with or at risk of hepatitis C virus infection remain uncertain. The benefit/risk ratio of Repatha when used for this indication in this patient population remains favourable. The safety of Repatha will continue to be monitored using the previously established Risk Management Plan.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.