Regulatory Decision Summary for REPATHA

The efficacy and safety of REPATHA were evaluated in several clinical trials. The results obtained from these trials showed that the treatment with REPATHA as adjunct to diet and exercise and maximally tolerated statin therapy reduced LDL-C levels in patients with heterozygous familial hyperlipidemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease (CVD). REPATHA reduced also LDL-C levels in patients with homozygous familial hypercholesterolemia (HoFH).

The effect of REPATHA on cardiovascular morbidity and mortality has not been determined.

REPATHA is supplied as solution in prefilled syringe and autoinjector for subcutaneous injection at the concentration of 140 mg/mL. The recommended dose of REPATHA is either 140 mg every 2 weeks or 420 mg once monthly for patients with HeFH or CVD. The dose for patients with HoFH is 420 mg once monthly or 420 mg every 2 weeks.

REPATHA should not be used in patients with a history of hypersensitivity reaction to REPATHA.

The safety profile of REPATHA is acceptable for the target population to be treated. In order to ensure that this benefit continues to outweigh any risk after authorization, Health Canada has required several post-approval activities to be carried out and a Risk Management Plan.

For more information on Health Canadas decision, please view the Summary Basis of Decision.