Summary of Cancellation for Lovenox and Lovenox HP
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:
Contact:
Medicinal ingredient(s):
enoxaparin sodium
Therapeutic area:
Antithrombotic Agents
Type of submission:
Supplement to a New Drug Submission
Control number:
292028
Decision issued:
No decision was issued by Health Canada. The Sponsor opted to withdraw and cancel the submission from review. Voluntary withdrawal of a submission does not disqualify a sponsor from refiling the application at a later date based on new evidence.
Date of cancellation:
2025-08-28
What was the purpose of this submission?
To expand the indication of the treatment and prevention of venous thromboembolism (VTE) with the addition of the “extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of its recurrence in adult patients with active cancer”.
What did the company submit to supports its submission?
The sponsor submitted clinical data, published studies, and labelling documentation. The pivotal clinical safety and efficacy information consisted of a retrospective cohort study (RIETECAT).
The retrospective cohort study (RIETECAT) compared the effectiveness and safety of enoxaparin sodium treatment regimens versus European-Union (EU) authorized low-molecular-weight heparins (LMWHs) in the extended treatment of DVT and PE and prevention of their recurrence in adults with active cancer over a 6-month period.
What was the status of the submission when it was cancelled? What was Health Canada’s assessment of the submission at the time of cancellation?
At the time of the cancellation, Health Canada’s review of the submission was still in progress. During the review, several major concerns were identified in the clinical efficacy evidence, including some related to patient population selection and the potential presence of multiple sources of bias. A request for revised analyses was communicated to the Sponsor. The Sponsor requested additional time to respond, which was granted. After consideration of Health Canada's request, the Sponsor made the decision to withdraw their submission.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
Lovenox and Lovenox HP are products that have authorization for marketing in Canada.
Manufacturer:
Sanofi-Aventis Canada Inc.
Drug Identification Numbers issued:
N/A
Date filed:
2024-11-06