Regulatory Decision Summary for Bamlanivimab

Decision issued

No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.

Date of cancellation

February 22, 2022

What was the purpose of this submission?

Bamlanivimab received authorization on November 20, 2020 under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (ISAD IO). Bamlanivimab was indicated for the treatment of adults and pediatric patients (12 years of age or older weighing 40 kg or more) with mild to moderate COVID-19 who are at high risk of progressing to severe COVID-19 illness and/or hospitalization.

This NDS-CV was submitted to transition the authorization from the Interim Order to the Food and Drug Regulations.

What did the company submit to supports its submission?

The clinical data provided at filing are identical to the data provided under COVID-19 Interim Order Application (COV19) which led to authorization on November 20, 2020. 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 authorization.

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