Regulatory Decision Summary for Alphanate
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?
The intent of this New Drug Submission (NDS) is to seek the market authorisation of Alphanate for the proposed indications of prevention and treatment of hemorrhage or surgical bleeding in adult and pediatric patients with von Willebrand Disease, when desmopressin (DDAVP) is known or suspected to be either ineffective or contraindicated. Based on efficacy data submitted, the proposed indications were revised to specify the type and the severity of the disease being treated.
Why was the decision issued?
Von Willebrand disease (vWD) is a congenital bleeding disorder caused by abnormalities of von Willebrand factor (vWF). In the absence of correction of the bleeding defect, patients may suffer from prolonged bleeding and delayed wound healing.
Clinical studies demonstrated that treatment with Alphanate was effective and safe as replacement therapy in prevention and treatment of mild and/or non-life-threatening bleeding episodes or bleeding during surgery in patients with von Willebrand Disease (but not for patients with severe vWD undergoing major surgeries).
To ensure the safety and efficacy of Alphanate treatment in patients with vWD, the proposed indications were revised to specify the type and the severity of the disease (vWD) being treated.
Alphanate was well tolerated at the recommended doses. The potential risks of treatment with Alphanate are described in the product monograph. Alphanate demonstrated a favorable benefit to risk profile for the prevention and treatment of mild and/or non-life-threatening bleeding episodes or surgical bleeding (except for patients with severe vWD undergoing major surgeries).
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| ALPHANATE | 02475561 | GRIFOLS BIOLOGICALS LLC | ANTIHEMOPHILIC FACTOR (HUMAN) 250 UNIT/VIAL VON WILLEBRAND FACTOR (HUMAN) 300 UNIT/VIAL |
| ALPHANATE | 02475626 | GRIFOLS BIOLOGICALS LLC | ANTIHEMOPHILIC FACTOR (HUMAN) 2000 UNIT/VIAL VON WILLEBRAND FACTOR (HUMAN) 2400 UNIT/VIAL |
| ALPHANATE | 02475618 | GRIFOLS BIOLOGICALS LLC | ANTIHEMOPHILIC FACTOR (HUMAN) 1500 UNIT/VIAL VON WILLEBRAND FACTOR (HUMAN) 1800 UNIT/VIAL |
| ALPHANATE | 02475588 | GRIFOLS BIOLOGICALS LLC | ANTIHEMOPHILIC FACTOR (HUMAN) 500 UNIT/VIAL VON WILLEBRAND FACTOR (HUMAN) 600 UNIT/VIAL |