Regulatory Decision Summary for Kerendia
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: Finerenone (*Kerendia)
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 5, 2021
What was the purpose of this submission?
This New Drug Submission (NDS) was filed to obtain market authorization for Kerendia (finerenone) to delay progression of kidney disease and to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) and hospitalization for heart failure in adults with chronic kidney disease and type 2 diabetes.
What did the company submit to support its submission?
The sponsor submitted quality, clinical and non-clinical data packages, as well as labelling information.
What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?
An initial review of the Fidelio renal outcomes trial was conducted and a number of uncertainties were identified and conveyed to the sponsor in a clinical clarification request sent on September 22, 2021. Subsequently, the NDS for Kerendia was cancelled by the sponsor as of October 5, 2021. At the time of cancellation, Health Canada’s review of the submission was not complete.
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:
Kerendia