Regulatory Decision Summary for Praluent

The purpose of this submission was to provide evidence supporting the registration of a new subcutaneous dosage form for Praluent (alirocumab): a 300 mg/2 mL solution for injection in a pre-filled auto-injector (AI), to allow administration of a 300 mg dose in a single 2 mL injection instead of two 1 mL injections. There is no change to the drug formulation, authorized indications or dosing regimens.

• The recommended dose of Praluent is 75 mg once every 2 weeks. A 150 mg every 2 weeks dose is used if the response is not adequate. A dosing interval of 300 mg every 4 weeks may be considered if the patient may benefit from less frequent dosing. View the Praluent Product Monograph for details.

• Authorization for the new subcutaneous dosage form for Praluent (300 mg/2 mL) in addition to the currently authorized 150 mg/mL presentation, was based on data from:

  • Study MSC14864: a multicenter, randomized, open-label, parallel-group 16-week usability study conducted in the United States. Patients were randomized 1:1 to the SYDNEY (single 2 mL injection using the new device) or auto-injector (AI; two 1 mL injections using the existing device) arms for the first 4 weeks (parallel-arm period). Subsequently, all patients switched to the new SYDNEY device arm from Week 4 to Week 16 (single-arm period).

• Use of the new device was generally experienced to be acceptable, with limited technical complaints (one incident [leaking of medication during the injection] out of 196 measurements, which was found to be user error).

• LDL-C reductions which were comparable to the AI device were observed with the SYDNEY device.

• The alirocumab exposure in serum after a single subcutaneous dose of 300 mg alirocumab via either a SYDNEY device or an AI device was comparable.

• The safety profile of Praluent observed in Study MSC14864 was consistent with the established alirocumab profile; no new safety concerns were identified.

• Overall, the benefit-risk profile for the new 300 mg/2 mL SYDNEY presentation was positive.

The chemistry and manufacturing information submitted for Praluent has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications.

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

Overall, the benefit-harm-uncertainty profile was favourable for Praluent for the approved indication when used under the conditions of use recommended in the approved Product Monograph. Therefore, a Notice of Compliance (NOC) was recommended.

For further details about Praluent, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.