ACTEMRA® IV (tocilizumab for injection) Receives Authorization for Additional Indication from Health Canada for the Treatment of COVID-19
- ACTEMRA is shown to improve outcomes including mortality in patients hospitalized with COVID-19 requiring supplemental oxygen.
- The authorization provides an additional option for hospitalized patients with COVID-19.
MISSISSAUGA, ON – October 28, 2022 - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that on October 13, 2022, Health Canada authorized ACTEMRA® IV (tocilizumab for injection) vials for the treatment of hospitalized adult patients with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids, and require supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation. The recommended dose of ACTEMRA for the treatment of adult patients with COVID-19 is a single intravenous infusion of 8 mg/kg administered over 60 minutes. Doses exceeding 800 mg per infusion are not recommended in patients with COVID-19.
“Actemra has been a cornerstone for treatment of moderate to severe COVID-19 since multiple large clinical trials have shown a positive benefit,” said Dr. Zain Chagla, Associate Professor of Medicine, McMaster University. “Actemra remains a part of national and international guidelines for therapy. This approval of Actemra for use in COVID-19 helps enable a long-term supply of medication in order to ensure optimal care for hospitalized patients with COVID-19.”
It is estimated that for every 1000 adults in hospital with COVID-19, 429 would be eligible for tocilizumab; treating them all may prevent 17 deaths and 12 instances of invasive mechanical ventilation.
Positive results from the Phase III RECOVERY study of ACTEMRA IV support the potential of ACTEMRA IV to offer a treatment option for adult patients diagnosed with COVID-19 who require hospitalization.
About the Health Canada Approval
The approval of ACTEMRA IV for the treatment of COVID-19 was based on Phase III data from the RECOVERY trial (Randomized Evaluation of COVID-19 Therapy) Collaborative Group Study in Hospitalized Adults Diagnosed with COVID-19. The RECOVERY trial was a randomized, controlled, open-label, multi-center platform study undertaken to evaluate the efficacy and safety of potential treatments in hospitalized adult patients with severe COVID-19. The trial was conducted entirely within the United Kingdom. Eligible patients (n=21 550) received usual care and underwent a main randomization to 0, 1, 2 or 3 additional treatments being investigated for use in the treatment of COVID-19.
Efficacy analyses considered the population comprising 4116 patients who were re-randomized to either tocilizumab + usual care (n=2022) or usual care alone (n=2094).
The primary outcome was time to death through Day 28. Overall, 621/2022 (31%) patients randomized to tocilizumab + usual care and 729/2094 (35%) patients randomized to usual care alone died within 28 days. The median time to hospital discharge was 19 days in the tocilizumab + usual care arm and >28 days in the usual care arm.
Among patients not requiring invasive mechanical ventilation at baseline, the proportion of patients who required mechanical ventilation or died by Day 28 was 35% (619/1754) in the tocilizumab + usual care arm and 42% (754/1800) in the usual care alone arm.
About ACTEMRA® (tocilizumab)
ACTEMRA was the first humanized interleukin-6 receptor-antagonist monoclonal antibody approved by Health Canada for both subcutaneous and intravenous administration in rheumatoid arthritis. The subcutaneous formulation has comparable efficacy and safety to the IV formulation.[6,7] ACTEMRA® is to be given in combination with methotrexate (MTX) or other DMARDs; however, in cases of intolerance to MTX or where treatment with MTX is not appropriate ACTEMRA® may also be given as monotherapy.
The extensive ACTEMRA clinical development program included five phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries, including Canada. ACTEMRA is also approved for the treatment of active systemic juvenile idiopathic arthritis (sJIA), polyarticular-course juvenile idiopathic arthritis (pJIA) in patients two years of age and older, for the treatment of Giant Cell Arteritis (GCA) in adult patients, and for chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS), in accordance with patient populations specified for authorized CAR T cell products.
Patients and science are at the heart of everything we do. At Roche, our passion for science and our commitment to relentlessly pursuing the impossible for patients has made us one of the world’s leading pharmaceutical, in vitro diagnostics, and healthcare technology companies. And we’re adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries.
We're an innovator across major disease areas, including oncology, infectious diseases, diabetes, ophthalmology, and diseases of the central nervous system.
Roche Canada was founded in 1931 and employs more than 1,800 people across the country through its Pharmaceuticals division in Mississauga, Ontario as well as its Diagnostics and Diabetes Care divisions in Laval, Quebec.
For more information, please visit www.RocheCanada.com or follow Roche Canada on LinkedIn, or on Twitter @RocheCanada.
For further information: Jennifer Mota, Strategic Communications, Hoffmann-La Roche Limited,
E: [email protected] T: 437-219-7806
1. Morris, A, et. al. Strategies to Manage Tocilizumab Supply During the COVID-19 Pandemic. Version 1.0, January 19, 2021. Available from: https://covid19-sciencetable.ca/wp-content/uploads/2021/04/Science-Brief_Tocilizumab-Rationing_20210419_published.pdf.
2. ACTEMRA Product Monograph, October 13, 2022.
3. ACTEMRA Product Monograph, October 13, 2022.
4. Verma, A, et. al. Managing drug shortages during a pandemic: tocilizumab and COVID-19. Available from: https://www.cmaj.ca/content/193/21/E771.short
5. ACTEMRA Product Monograph, October 13, 2022.
6. Burmester G et al. A randomized, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTA study). Ann Rheum Dis 2013; 0:1–6. doi:10.1136/annrheumdis-2013-203523.
7. Kivitz A et al. A Randomized, Double-Blind, Parallel-Group Study of the Safety and Efficacy of Tocilizumab Subcutaneous Versus Placebo in Combination With Traditional DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis (BREVACTA). ACR, November 2012.
8. ACTEMRA Product Monograph, October 13, 2022.