Regulatory Decision Summary for Nordapro
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:
Summary of Cancellation: Aprotinin (Nordapro)
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. The company chose to cancel its submission before a final decision was issued.
Date of cancellation
February 1, 2022
What was the purpose of this submission?
The purpose of this New Drug Submission (NDS) was to support the use of Nordapro (Aprotinin, solution for intravenous administration), for prophylactic risk management of excessive bleeding, transfusion and re-exploration for 1) Patients undergoing high-risk cardiac surgery, and 2) High-risk patients undergoing cardiac surgery.
High-risk cardiac surgeries include, for example, aortic dissection repair, multiple valve operations, and combined coronary artery bypass graft and valve operations. High-risk patients include, for example, those presenting characteristics such as low platelet count, platelet dysfunction, antiplatelet therapy, or refusal of blood transfusion.
What did the company submit to support its submission?
The results from a post-authorization safety study (a patient registry) in patients who underwent cardiac surgery and who received Nordapro were provided. A systematic literature review of aprotinin used in cardiac surgery was also provided. In addition, two retrospective analyses comparing efficacy and safety of Nordapro and Trasylol were included in the submission package aimed to bridge the two products.
What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?
At the time of the cancellation, Health Canada completed the assessment of the data provided to support the proposed indication. The clinical efficacy and safety data provided are not considered to meet the regulatory requirements to confirm the clinical benefit of using Nordapro for the proposed indication.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
It is unlikely that the cancellation would have an impact for patients accessing the drug under the Special Access Programme.
Additional information
*Proposed Brand Name:
Nordapro