Regulatory Decision Summary for Aduhelm
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: Aducanumab (Aduhelm)
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
May 27, 2022
What was the purpose of this submission?
A New Drug Submission (NDS) was filed by the sponsor to obtain marketing authorization for Aduhelm (aducanumab) to be used as a disease modifying treatment for Alzheimer’s disease in adults.
What did the company submit to support its submission?
The sponsor submitted drug quality, pre-clinical and clinical components in support of their application. The pivotal safety and efficacy information consisted of two identically designed phase 3 clinical trials that were completed contemporaneously. Studies were to assess the efficacy and safety of aducanumab in participants with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s disease dementia. Following the initial pre-specified interim analysis, both studies were terminated for futility. The final data set filed for this submission is based on subsequent analyses.
What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?
At the time of cancellation, Health Canada completed the assessment of the data provided to support the proposed indication. The clinical efficacy and safety data that were provided did not support the clinical benefit of using Aduhelm for the proposed indication. The Sponsor chose to cancel their submission without prejudice to refiling.
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 in clinical trials. At this time, Aduhelm is not available under the SAP.
For more information about the Special Access Programme refer to the programme’s web site: http://www.healthcanada.gc.ca/sap or http://www.santecanada.gc.ca/pas
Additional information
*Proposed Brand Name:
Aduhelm