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.


Product type:

Drug

Medicinal ingredient(s):

Evolocumab

Therapeutic area:

N/A

Type of submission:

Supplement to a New Drug Submission

Control number:

208904
What was the purpose of this submission?

 

The purpose of this submission was to seek market authorization to expand the indication for REPATHA to include adult patients with hyperlipidemia, as an adjunct to diet, alone or in combination with other lipid-lowering therapies, to reduce low density lipoprotein cholesterol (LDL-C). After evaluation of the submitted data package, Health Canada authorized REPATHA for the following indication:

Primary Hyperlipidemia (including Heterozygous Familial Hypercholesterolemia)
REPATHA is indicated for the reduction of elevated low density lipoprotein cholesterol (LDL-C) in adult patients with primary hyperlipidemia (including heterozygous familial hypercholesterolemia):

  • as an adjunct to diet and statin therapy, with or without other lipid-lowering therapies, in patients who require additional lowering of LDL-C
  • as an adjunct to diet, alone or in combination with non-statin lipid-lowering therapies, in patients for whom a statin is contraindicated.

 

Why was the decision issued?

 

Authorization was based on three (3) international, multi-centre, randomized, double-blind, placebo- and/or active-controlled clinical trials. Across these three trials, 3,104 patients with primary hyperlipidemia (with elevated low density lipoprotein cholesterol, LDL-C), with or without clinically evident atherosclerotic cardiovascular disease, received either REPATHA (140 mg every 2 weeks or 420 mg once monthly), placebo (every 2 weeks or once monthly) or ezetimibe (10 mg orally daily) for 12, 24 or 52 weeks. The primary efficacy endpoint was the mean percent change in serum LDL-C from baseline to the end of each study. Across the studies, REPATHA treatment resulted in significantly lower LDL-C compared to placebo or ezetimibe treatment. The difference in REPATHAs LDL-C lowering effect vs. placebo ranged from -59% to -74%; the difference vs. ezetimibe ranged from -38 to -45%. Authorization was further supported by other clinical studies, including a study that demonstrated that REPATHA provides a clinically relevant cardiovascular benefit. The safety profile of REPATHA across these trials was similar to the safety profile of REPATHA as currently indicated. Identified risks of REPATHA include, but are not limited to, diabetes mellitus, nasopharyngitis, upper respiratory tract infections, injection site reactions, and allergic reactions. The ratio of benefits to risks of REPATHA remains favourable when it is used according to the revised indication.

 

Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.