Regulatory Decision Summary for PRALUENT

The efficacy and safety of Praluent were evaluated in 5 placebo-controlled phase 3 clinical trials. The results obtained from these trials showed that the treatment with Praluent as adjunct to diet and exercise and maximally tolerated statin therapy reduced LDL-C levels in adult patients with heterozygous familial hyperlipidemia (HeFH) or patients with non-familial hyperlipidemia and with history clinical atherosclerotic cardiovascular disease (CVD).

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

Praluent is supplied as solution in prefilled syringes and in prefilled pens for subcutaneous injection at the concentration of 75 mg/mL and 150 mg/mL. The recommended dose of Praluent is 75 mg once every 2 weeks. If the LDL-C response is inadequate, the dosage may be increased to the maximum dosage of 150 mg administered every 2 weeks.

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

The safety profile of Praluent 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.