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ACTEMRA has been shown to have results, adding mortality in hospitalized COVID-19 patients requiring supplemental oxygen. 1
The authorization provides an additional option for hospitalized COVID-19 patients.
MISSISSAUGA, ON, Oct. 28, 2022 /PRNewswire/ — Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that on October 13, 2022, Health Canada’s legal vials of ACTEMRA® IV (tocilizumab for injection) for the remedy of inpatient patients with adult coronavirus disease 2019 (COVID-19) receiving systemic corticosteroids and requiring supplemental oxygen, noninvasive or invasive mechanical ventilation or extracorporeal membrane oxygenation. 2 The recommended dose of ACTEMRA for the treatment of adult patients with COVID-19 is a simple intravenous infusion of 8 mg/kg administered over 60 minutes. Doses higher than 800 mg compatible with the infusion are not recommended for patients with COVID-19. 3
“Actemra has been the cornerstone of treating moderate to severe COVID-19, as several giant clinical trials have demonstrated a positive benefit,” said Dr. Zain Chagla, associate professor of medicine at McMaster University. Remedy guidelines. This approval of Actemra for use in COVID-19 allows for a long-term source of medicines to ensure optimal care for hospitalized COVID-19 patients. “
It is estimated that for every 1,000 adults hospitalized with COVID-19, 429 would be eligible for tocilizumab; Treating them all can save you 17 deaths and 12 cases of invasive mechanical ventilation. 4
The positive effects of the phase III RECOVERY study of ACTEMRA IV confirm the possibility that ACTEMRA IV will provide a treatment option for adult patients diagnosed with COVID-19 who require hospitalization.
About Health Canada Approval
The approval of ACTEMRA IV for the treatment of COVID-19 is based on Phase III data from the collaborative organization RECOVERY (Randomized Evaluation of COVID-19 Therapy) in hospitalized adults diagnosed with COVID-19. The RECOVERY trial was a randomized, controlled trial A multicenter, open-label platform examination was conducted to compare the efficacy and protection of prospective remedies in hospitalized adult patients with severe COVID-19. more remedies under study for use in the treatment of COVID-19.
Efficacy analyzes the population of 4116 patients who were randomly reassigned to receive tocilizumab with the same previous care (n=2022) or the same previous care alone (n=2094).
The number one final results time until death until day 28. Overall, 621/2022 (31%) patients randomized to receive tocilizumab with the same previous care and 729/2094 (35%) patients randomized to the same previous care alone died within 28 days. The median time to discharge from hospital 19 days in the same previous care organization and > 28 days in the same previous care organization. 5
Among patients who did not require initial invasive mechanical ventilation, the proportion of patients who required mechanical ventilation or who died on day 28 35% (619/1754) in the same anterior care arm and 42% (754/1800) in the arm alone the same old care arm.
About ACTEMRA® (tocilizumab)
ACTEMRA was the first humanized monoclonal interleukin-6 receptor antagonist approved by Health Canada for the subcutaneous and intravenous treatment of rheumatoid arthritis. Subcutaneous formulations have comparable efficacy and protection to IV formulas. 6,7 ACTEMRA® deserves to be administered in mixture with methotrexate (MTX) or other DMARDs; however, in cases of MTX intolerance or when MTX treatment is not appropriate, ACTEMRA® may also be given as monotherapy.
ACTECRA’s extensive clinical progression program included five phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries in addition to Canada. ACTEMRA is also approved for the treatment of active systemic juvenile idiopathic arthritis (JIA), polyarticular juvenile idiopathic arthritis (pJIA) in patients two years of age and older, giant mobile arteritis (GCA) in adult patients, and severe or life-threatening chimeric antigen receptor-induced cytokine release syndrome (CRS). according to the patient populations specified for legal requirements. Mobile products CAR T. 8
About Roche
Patients and science are at the center of everything we do. At Roche, our fondness for science and commitment to relentlessly pursuing the goal of patients has made us one of the world’s leading pharmaceutical, IVS and healthcare generation companies. Experience in new areas, such as synthetic intelligence, real-world knowledge gathering and analysis, and collaboration with many other sectors and industries.
We are innovators in key areas of disease, adding oncology, infectious diseases, diabetes, ophthalmology and diseases of the central nervous system.
Roche Canada was founded in 1931 and employs over 1800 people nationwide through its pharmaceutical department in Mississauga, Ontario, as well as its Diabetes Diagnosis and Care departments in Laval, Quebec.
For more information, visit www. RocheCanada. com or join Roche Canada on LinkedIn or Twitter @RocheCanada.
1 Morris, A, et. Al. Strategies to manage tocilizumab cause 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, 13 October 2022. 3 ACTEMRA Product Monograph, 13 October 2022. 4 Verma, A, et. Al. Managing Drug Pandemic Shortages: Tocilizumab and COVID-19. Available in: https://www. cmaj. ca/content/193/21/E771. short5 Product monograph ACTEMRA, 13 October 2022. 6Burmester G et al. A randomized, double-blind, parallel-group study of the protection and efficacy of subcutaneous tocilizumab compared with intravenous tocilizumab in combination with classic disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTA examination). 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 protection and efficacy of subcutaneous tocilizumab compared to placebo in combination with classic DMARDs in patients with moderate to severe rheumatoid arthritis (BREVACTA). CAB, November 2012. 8 Product monograph ACTEMRA, October 13, 2022.
SOURCE Roche Canada
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