Regulatory Decision Summary for Bamlanivimab

Health Canada decision issued:

Bamlanivimab 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:

November 20, 2020

Indication (use):

The following is the indication for bamlanivimab for use in relation to COVID-19: Bamlanivimab is indicated for the treatment of adults and pediatric patients 12 years of age or older with mild to moderate coronavirus disease 2019 (COVID-19), who weigh at least 40 kg and who are at high risk of progressing to severe COVID-19 illness and/or hospitalization.

Health Canada analysis of known and potential benefits and known and potential risks:

Bamlanivimab is a neutralizing IgG1 monoclonal antibody directed against the SARS-CoV-2 spike protein. Authorization of bamlanivimab under the COVID-19 Interim Order is based on an interim analysis of the BLAZE-1 Phase 2 randomized, double-blind, placebo-controlled clinical trial studying bamlanivimab for the treatment of subjects with mild to moderate COVID-19 (subjects with COVID-19 symptoms who are not hospitalized). The study did not meet its primary efficacy endpoint of viral load reduction at day 11 for bamlanivimab compared to placebo. However, a potential benefit of bamlanivimab in patients was observed in the predefined secondary endpoint of COVID-19-related hospitalizations or emergency room visits within 29 days after treatment. Numerically, a lower proportion of bamlanivimab-treated subjects progressed to COVID-19-related hospitalization or emergency room visits compared to placebo-treated subjects. This included the indicated subset of patients who were considered high risk for developing severe COVID-19 symptoms.

The safety of a single dose of bamlanivimab was acceptable. The treatment-emergent adverse events (TEAEs) were reported in a similar proportion between placebo and bamlanivimab treated patients. The majority of TEAEs were graded as mild to moderate in all study arms with no apparent differences observed. The most important adverse reactions associated with bamlanivimab are infusion reactions, hypersensitivity reactions and, potentially, anaphylactic reactions. These types of reactions are of concern for monoclonal antibodies in general. It is noted that there were no clear increases in hypersensitivity or anaphylactic reactions when the bamlanivimab monotherapy was compared to placebo.

Given the high unmet medical need and emergency context of the COVID-19 pandemic, Health Canada considers the potential benefits outweigh the potential risks for bamlanivimab in its proposed use. An authorization under the COVID-19 Interim Order is recommended for the indication of treatment of adults and pediatric patients 12 years of age or older with mild to moderate COVID-19, who weigh at least 40 kg and who are at high risk of progressing to severe COVID-19 illness and/or hospitalization. Bamlanivimab should not be used in patients hospitalized with severe COVID-19 respiratory disease.

Directions for use:

Bamlanivimab is formulated as a solution for infusion (35 mg/mL) and the recommended dose is a single infusion of 700 mg to be administered as soon as possible after a positive test for COVID-19 and to be administered within 10 days following the onset of clinical signs and symptoms of infection. For more information, refer to the Product Monograph for Bamlanivimab.

Terms and Conditions:

Terms and conditions were imposed upon the authorization.