Regulatory Decision Summary for KOVALTRY
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:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
This New Drug Submission (NDS) was submitted to seek marketing authorization for use of Kovaltry (recombinant antihemophilic factor VIII) in adults and children with hemophilia A for:
- Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes
- Control and prevention of episodic bleeding
- Peri-operative management (surgical prophylaxis)
Why was the decision issued?
The safety, efficacy and pharmacokinetics of Kovaltry were evaluated in three multicenter, open-label, clinical trials (Leopold I study, Leopold II study, and Leopold Kids Study Part A), including a total of 204 male previous treated patients (PTPs) with severe hemophilia A (≤1% FVIII activity).
The safety profile of Kovaltry derived from the three clinical trials is considered acceptable. The benefits of Kovaltry have been showed in routine prevention, control of bleeding episodes, and perioperative management. The benefit/risk analysis is considered favorable for Kovaltry to be used as an alternative therapy for hemophilia A patients for prophylactic/on-demand treatment of bleeding episodes and perioperative management.
The Risk Management Plan was reviewed and considered acceptable for the Canadian context, and the proposed risk minimization plan is sufficient at this time.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| KOVALTRY | 02451476 | BAYER INC | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000 UNIT / VIAL |
| KOVALTRY | 02451492 | BAYER INC | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 3000 UNIT / VIAL |
| KOVALTRY | 02451441 | BAYER INC | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNIT / VIAL |
| KOVALTRY | 02451468 | BAYER INC | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNIT / VIAL |
| KOVALTRY | 02451484 | BAYER INC | ANTIHEMOPHILIC FACTOR (RECOMBINANT) 2000 UNIT / VIAL |