GSK receives authorization under Health Canada’s Interim Order for Sotrovimab for Injection to treat COVID-19 in high-risk adults and adolescents

Mississauga, Ontario – GSK announced today that Health Canada has granted an Interim Order authorization for Sotrovimab for Injection (sotrovimab, previously VIR-7831) for the treatment of mild to moderate COVID-19, confirmed by direct SARS-COV-2 viral testing, in adults and adolescents (12 years of age and older weighing at least 40 kg) who are at high risk for progressing to hospitalization and/or death[i].

The authorization of sotrovimab, a single-dose monoclonal antibody developed in collaboration with Vir Biotechnology, was granted under Health Canada’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. Health Canada’s Interim Order expedites authorization of medicines used for COVID-19, considering public health need.

“Health Canada’s authorization of sotrovimab marks a significant advance in COVID-19 treatment for Canadians. With results from the interim analysis demonstrating a reduction in hospitalizations or death, clinicians now have an evidence-based early therapeutic option for non-hospitalized patients with COVID-19 who are at high risk, potentially allowing them to avoid hospitalization or death,” said Dr. Anil Gupta, MD,CCFP,FCFP, family physician at William Osler Health Centre and lead investigator of the COMET-ICE trial (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early).

Health Canada’s Interim Order authorization of sotrovimab is based on the interim analysis results from the pivotal Phase 3 trial, COMET-ICE.

“Pursuing new treatments like sotrovimab must continue in tandem and with equal effort to vaccines to defeat the COVID-19 pandemic, particularly considering the emergence of variants across the country and around the world,” said Faris El Refaie, President & General Manager, GSK Canada. “With Health Canada’s Interim Order authorization of sotrovimab, we remain unwavering in our commitment to find options to optimize access for those who will benefit most from it, such as older adults and individuals with certain chronic medical conditions that could put them at higher risk of hospitalization or death due to COVID-19.”

Please consult the Product Monograph at www.gsk.ca for complete safety information. The Product Monograph is also available by calling 1-800-387-7374.

About the Vir and GSK Collaboration

In April 2020, Vir and GSK began collaborating on researching and developing solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies are leveraging GSK’s expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They are also applying their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. Please visit www.ca.gsk.com for further information.

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company that combines immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.