Regulatory Decision Summary for Innohep
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 for Innohep Control number 199839
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
LEO Pharma Inc. cancelled the submission before a final decision was issued by Health Canada.
Date of cancellation
2018-11-22
What was the purpose of this submission?
The purpose of this submission is to revise the current indications for Innohep to include an additional product claim for treating patients with Cancer Associated Thrombosis and to revise the associated duration of use for Innohep 20,000 anti-Xa IU/mL, as follows:
- Proposed New Indication: The extended treatment of venous thromboembolism and prevention of recurrence in patients with cancer.
- Revised Duration of Use Statement: A dose of 175 anti-XA IU/kg body weight given subcutaneously once daily is recommended for a treatment period of 6 months.
What did the company submit to support its submission?
LEO Pharma Inc. provided clinical data, published studies and labelling documentation.
What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?
The review was ongoing at the time of cancellation. Health Canadas assessment of the submission had identified some issues with the evidence that was available to provide support for the revised indication. These issues were not resolved by the time the sponsor cancelled the submission.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
This decision is not expected to impact SAP or clinical trial access to this drug
Additional information
Proposed Brand Name:
Innohep Injection