Regulatory Decision Summary for Stendra
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: Stendra
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation
October 5, 2021
What was the purpose of this submission?
The purpose of this New Drug Submission (NDS) for Stendra (avanafil), a phosphodiesterase-type 5 (PDE5) selective inhibitor, was to seek market authorization for the treatment of erectile dysfunction (ED).
What did the company submit to support its submission?
The company submitted the results of 18 Phase I, 4 Phase II, 4 Phase III and 2 Phase IV clinical studies to support the submission, including data from 18 Phase I, 4 Phase II, 4 Phase III and 2 Phase IV studies. In addition, the sponsor submitted quality and non-clinical data, labelling information, and a Risk Management Plan (RMP).
Improvements in ED were observed across subgroups defined by age, race, ED severity, ED duration, hypertension, diabetic status and nerve-sparing total prostatectomy.
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?
Health Canada’s review of the submission was incomplete when the submission was cancelled.
At the time of cancellation, the pre-clinical and clinical evidence with respect to the safety and efficacy of the drug had been reviewed and found to be acceptable. Health Canada had identified issues during the assessment of the quality data, regarding the lack of an assessment of the control for certain impurities. Health Canada issued a Notice of Deficiency (NOD) for this submission on April 16, 2020. A response to the NOD was filed and reviewed by Health Canada but quality-related issues remained. The sponsor subsequently decided to cancel the submission.
What consequences does the cancellation have for patients accessing the drug under the Special Access Program (SAP), or via clinical trials?
Similar PDE5 inhibitors with the same indication and similar safety profiles are available on the Canadian market. No consequences are anticipated for the targeted patients to access effective treatments in Canada due to the cancellation of this submission.