Mississauga, On, 10.06.2021
Health Canada grants Interim Order authorization for casirivimab and imdevimab for the treatment of mild to moderate COVID-19
MISSISSAUGA, ON, June 10, 2021 – Hoffmann-La Roche Limited (Roche Canada) today announced that Health Canada has issued an Interim Order authorization for casirivimab and imdevimab (REGN-COV2), to be administered together, for the treatment of mild to moderate coronavirus disease 2019 (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.2 Patients who are at higher risk of contracting severe COVID-19 present with one or more of the following risk factors: Advanced age (50 years of age or older), irrespective of comorbidities, or 18 years of age or older and presence of one of the following comorbidities: obesity, cardiovascular disease, chronic lung disease, diabetes, chronic kidney disease, chronic liver disease, immunosuppressed based on prescribers’ assessment.3
“As a healthcare solutions company, Roche has an integral role to play during the COVID-19 pandemic, and we are proud to be leading the way and bringing important therapeutics to patients in Canada,” says Loredana Regep, Vice President, Medical and Regulatory Affairs, Hoffmann-La Roche Limited. “We stand together with governments, healthcare providers and all those working to overcome the pandemic.”
Health Canada’s Interim Order is applied when the Minister of Health believes immediate action is required to deal with a significant risk to health, safety or the environment.4 The Interim Order authorization for the combination of casirivimab and imdevimab is associated with terms and conditions that need to be met by Roche Canada, pending the results of trials to ascertain the continued quality, safety and efficacy of the product.5
The Health Canada interim authorization is based on interim results of the Phase I/II/III REGN-2067 adaptive trial that showed a reduction in the number of patients with a COVID-19-related hospitalization or all-cause death in non-hospitalized patients with COVID-19 symptoms who were treated with the combination of casirivimab and imdevimab compared to placebo.6
About the REGN-2067 study
REGN-2067 is a randomized, double-blinded, placebo-controlled Phase I/II/III clinical trial studying the combination of casirivimab with imdevimab for the treatment of non-hospitalized adults with mild or moderate COVID-19 symptoms.7 Of the 4567 patients with SARS-CoV-2 infection randomized in the Phase III trial, 14% were 65 years or older, and 4% were 75 years of age or older.8 All 4567 symptomatic patients were randomized in a 1:1:1 manner to receive a single intravenous (IV) infusion of 1200 mg combined dose of casirivimab and imdevimab (600 mg of each), 2400 mg combined dose of casirivimab and imdevimab (1200 mg of each), 8000 mg combined dose of casirivimab and imdevimab (4000 mg of each), or placebo (n=266, n=267, n=266, respectively).9
The study duration was 28 days for each patient.10 Throughout the study nasopharyngeal (NP) swab samples were collected along with information about any medically attended visits related to COVID-19.11
The trial enrolled adult subjects who were not hospitalized and had at least one or more COVID-19 symptoms that were at least mild in severity. Treatment of patients with casirivimab and imdevimab reduced COVID-19 related medical visits by 70% at day 29 (1.3% casirivimab and imdevimab combined dose groups; 4.6% placebo; p<0.0001).12
The adverse events collected were infusion-related reactions and hypersensitivity reactions of moderate severity or higher through day 29.13 Infusion-related reactions may include fever, chills, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness.14
About Casirivimab and Imdevimab
Casirivimab and imdevimab are being studied for their potential both to prevent infection and treat people already infected with SARS-CoV-2. Casirivimab and imdevimab are monoclonal antibodies that are specifically targeted against the SARS-CoV2 virus. The two antibodies bind to distinct regions of the receptor binding domain (RBD) of the virus' spike protein, preventing the virus from infecting healthy cells and diminishes escape mutants.15
The recommended dose of casirivimab and imdevimab is 1200 mg of casirivimab and 1200 mg of imdevimab administered together as a single intravenous infusion by a qualified health professional using an aseptic technique.16 It should be administered over 60 minutes.17
COVID-19 is the disease caused by the novel coronavirus, SARS-CoV-2. It was declared a global pandemic by the World Health Organization in March 2020. Among those who develop symptoms, about 15% become seriously ill and require oxygen and 5% become critically ill and need intensive care.18
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare - a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1931, Roche Canada is committed to searching for better ways to prevent, diagnose and treat diseases while making a sustainable contribution to society. The company employs more than 1,500 people across the country through its Pharmaceuticals division in Mississauga, Ontario and Diagnostics, as well as Diabetes Care divisions in Laval, Quebec.
Roche aims to improve patient access to medical innovations by working with all relevant stakeholders. Roche Canada is actively involved in local communities through its charitable giving and partnerships with organizations and healthcare institutions that work together to improve the quality of life of Canadians. For more information, please visit www.RocheCanada.com.
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© Copyright 2021; Hoffmann-La Roche Limited
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1. Casirivimab and imdevimab product monograph, June 9, 2021.
2. Casirivimab and imdevimab product monograph, June 9, 2021.
3. Casirivimab and imdevimab product monograph, June 9, 2021.
4. Government of Canada. Interim order respecting the importation and sale of medical devices for use in relation to COVID-19. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/interim-order-importation-sale-medical-devices-covid-19.html. (Accessed March 2021)
5. Casirivimab and imdevimab product monograph, June 9, 2021.
6. Casirivimab and imdevimab product monograph, June 9, 2021.
7. Casirivimab and imdevimab product monograph, June 9, 2021.
8. Casirivimab and imdevimab product monograph, June 9, 2021.
9. Casirivimab and imdevimab product monograph, June 9, 2021.
10. Casirivimab and imdevimab product monograph, June 9, 2021.
11. Casirivimab and imdevimab product monograph, June 9, 2021.
12. Casirivimab and imdevimab product monograph, June 9, 2021.
13. Casirivimab and imdevimab product monograph, June 9, 2021.
14. Casirivimab and imdevimab product monograph, June 9, 2021.
15. Weinreich, David M et al. REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19. The New England Journal of Medicine vol. 384,3 (2021): 238-251. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2035002. (Accessed March 2021)
16. Casirivimab and imdevimab product monograph, June 9, 2021.
17. Casirivimab and imdevimab product monograph, June 9, 2021.
18. World Health Organization. Coronavirus Disease (COVID-19). Available at: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/question-and-answers-hub/q-a-detail/coronavirus-disease-covid-19. (Accessed March 2021)