Regulatory Decision Summary for Roxadustat (*Hifrenzo)
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: roxadustat (*Hifrenzo)
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
October 29, 2021
What was the purpose of this submission?
This New Drug Submission (NDS) was filed to obtain market authorization for Hifrenzo (roxadustat) for treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis and not on dialysis.
What did the company submit to support its submission
The sponsor submitted quality, clinical and non-clinical data packages, as well as labelling information and a post-market Risk Management Plan. This submission was being reviewed as part of an international work-sharing (IWS) project with the Therapeutic Goods Administration (TGA-Australia) and Health Sciences Authority (HSA-Singapore).
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?
A Notice of Non-Compliance (NON) was previously issued for this product on January 25, 2021. A response to the NON was filed and reviewed by Health Canada. Remaining issues were identified during the review of the response. The sponsor subsequently decided to cancel the submission.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
There is no expected impact for patients using SAP or in clinical trials.
Additional information
*Proposed Brand Name:
Hifrenzo