Regulatory Decision Summary for Casirivimab and imdevimab
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 the rationale for authorization for use in relation to the COVID-19 pandemic: casirivimab and imdevimab
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Health Canada decision issued:
Casirivimab and imdevimab was authorized for use in relation to the COVID-19 pandemic, in accordance with section 5 of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
Date of decision:
June 9, 2021
Indication (use):
The following is the indication for casirivimab and imdevimab for use in relation to COVID-19:
Casirivimab and imdevimab, to be administered together, are indicated for the treatment of mild to moderate coronavirus disease 2019, confirmed by direct SARS-CoV-2 viral testing, in adults and adolescents (aged 12 years and older weighing at least 40 kg) who are at high risk for progression to hospitalization and/or death.
Health Canada analysis of known and potential benefits and known and potential risks:
The efficacy of casirivimab and imdevimab was studied in a phase 1/2/3 master protocol, placebo-controlled, double-blind, randomized, single-dose study of casirivimab and imdevimab, administered in combination, to outpatients diagnosed with mild to moderate COVID-19 illness. Phase 3 (cohort 1) of the study determined the efficacy of the product in reducing the number of hospitalizations due to COVID-19 and/or all-cause death in patients who were considered to be at high-risk of hospitalization due to COVID-19. The study successfully demonstrated statistically significant reductions in the numbers of hospitalisations and/or deaths among treated patients compared to those who received placebo.
The safety of a single dose of casirivimab and imdevimab combination treatment was acceptable. The most important adverse reactions associated with this combination treatment are infusion-related reactions, hypersensitivity reactions and anaphylactic reactions. These types of reactions are of concern for monoclonal antibodies in general but were observed rarely in all phases of the ongoing clinical study.
Health Canada considers the potential benefits outweigh the potential risks for casirivimab and imdevimab combination treatment when used as per the product monograph directions.
The authorization of casirivimab and imdevimab is associated with Terms and Conditions that need to be met by the sponsor to ascertain the continued quality, safety and efficacy of the product. Patients should be advised of the nature of the authorization. For further information on the nature of this authorization, please refer to Health Canadas IO Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
Directions for use:
Casirivimab and imdevimab are administered together as a single intravenous infusion of 2400 mg (1200 mg casirivimab + 1200 mg imdevimab). The infusion should be administered over 1 hour. Patients should be monitored for 1 hour after infusion.
For more information, refer to the Product Monograph for casirivimab and imdevimab.
Terms and Conditions:
Terms and conditions were imposed upon the authorization.