Regulatory Decision Summary for Bamlanivimab and Etesevimab
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: Bamlanivimab and Etesevimab
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
February 20, 2022
What was the purpose of this submission?
A COVID-19 Interim Order Application (COV19) was filed for Etesevimab on February 17, 2021 in accordance with the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (ISAD IO). The review of the application could not be completed in time for the IO expiry date of September 16, 2021.
The Sponsor proposed that Etesevimab, which is to be administered together with Bamlanivimab, be indicated for the treatment of adults and pediatric patients (12 years of age or older and weighing 40 kg or more) with mild to moderate coronavirus disease 2019 (COVID-19), who are at high risk of progressing to severe COVID-19 illness and/or hospitalization.
This NDS-CV is being submitted to transition the authorization under the Food and Drug Regulations.
What did the company submit to supports its submission?
The submission included nonclinical data and the sponsor conducted phase 2 clinical trial (J2W-MC-PYAB, also termed PYAB and BLAZE-1) demonstrating efficacy against the circulating viral variants at the time of review.
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 cancellation, the review of the submission was ongoing. The sponsor chose to cancel the submission due to the changes in global variant landscape and may re-file at a later date.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
There is no impact for patients accessing the drug under the SAP or in clinical trials.
For more information about the Special Access Program refer to the programme’s web site: http://www.healthcanada.gc.ca/sap or http://www.santecanada.gc.ca/pas