Health Canada approves two therapies for COVID-19 treatment

Health Canada has authorized two new treatments for COVID-19: the intravenous (IV) formulation of Actemra (tocilizumab for injection) and Evusheld (tixagevimab and cilgavimab injection). Actemra The IV formulation of Hoffmann-La Roche’s Actemra (tocilizumab for injection) is now indicated for the treatment of hospitalized adults with COVID-19. It is intended only for adults who are receiving systemic corticosteroids, and require supplemental oxygen, noninvasive or invasive mechanical ventilation or extracorporeal membrane oxygenation. It is not recommended in patients with certain laboratory abnormalities: liver enzymes ≥ 10 times the upper limit of normal, an absolute neutrophil count < 1 x 109/L or a platelet count < 50 x 103 /μL.1 Read: LTC seniors three times more likely to receive antidepressants than other seniors The IV formulation of Actemra was approved earlier by Health Canada for treatment of rheumatoid arthritis, polyarticular and systemic juvenile idiopathic arthritis, and cytokine release syndrome.1 It was being used off-label for COVID-19 treatment and is one of the options recommended for treating critically ill patients in the latest COVID-19 treatment guidelines published by the (now-disbanded) Ontario COVID-19 Science Advisory Table.2 The manufacturer’s recommended dosage of Actemra for treatment of COVID-19 in hospitalized adults is a single IV infusion of 8 mg/kg (maximum 800 mg) administered over 60 minutes. One additional 8 mg/kg IV infusion may be given at least eight hours after the initial infusion if clinical signs or symptoms worsen or do not improve after the first dose.1 In drug shortage situations, the Ontario COVID-19 Science Advisory Table recommends a single dose of tocilizumab 400 mg IV for all eligible patients and a second dose should not be given to any patient.2 Evusheld AstraZeneca’s Evusheld (tixagevimab and cilgavimab injection), a long-acting antibody combination, is now indicated for the treatment of mild to moderate COVID-19 in adults and adolescents (≥12 years of age weighing at least 40 kg).3 A single dose of 600 mg is recommended for treatment, administered as two separate 3 mL sequential intramuscular injections of tixagevimab 300 mg and cilgavimab 300 mg, preferably one injection in each gluteal muscle. The drugs should be given as soon as possible after a positive viral test for SARS-CoV-2 and within seven days after the onset of symptoms.3 Read: CMAJ report calls for substantial healthcare restructuring to tackle long-COVID burden Approval was based on the results of the TACKLE trial in nonhospitalized patients who had not received COVID-19 vaccination; 90% of patients were considered at higher risk of progressing to severe COVID-19 due to their age (≥ 65 years) or the presence of co-morbidities. Results found the incidence of severe COVID-19 or death from any cause to be 4.4% in patients given Evusheld within seven days of symptom onset, compared to 8.8% in those who received placebo.3,4 Evusheld was originally approved only for the pre-exposure prophylaxis of COVID-19 in adults and adolescents (≥12 years of age weighing at least 40 kg). When used prophylactically, the drug combination is intended for patients with no known recent exposure to an individual infected with SARS-CoV-2 and who are immune compromised and unlikely to mount an adequate immune response to COVID-19 vaccination or for patients in whom COVID-19 vaccination is not recommended.3 In a press release announcing the approval of Evusheld for COVID-19 treatment, Dr. Zain Chagla, Associate Professor, Medicine, Faculty of Health Sciences, McMaster University commented that "Certain Canadians continue to be vulnerable to poor outcomes from COVID-19 and having a new treatment option in our arsenal, particularly one that is given as a single dose, is especially welcome news as we move into the winter months when we expect case counts to rise."4 The manufacturer reports that Evusheld has been shown to retain in vitro neutralization activity against the main Omicron variants currently circulating globally, including BA.5 and BA.2.4 However, the product monograph cautions that circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies. Healthcare professionals should routinely review current literature and local guidelines for details regarding specific variants and resistance.3 References 1. Hoffmann-La Roche Ltd. Actemra (tocilizumab for injection) product monograph. Mississauga, ON, October 13, 2022. (accessed October 20, 2022). 2. Ontario COVID-19 Science Advisory Table. Therapeutic management of adult patients with COVID-19. Version 11.0. April 1, 2022. (accessed October 20, 2022). 3.AstraZeneca Canada Inc. Evusheld (tixagevimab and cilgavimab injection) product monograph. Mississauga, ON, October 18, 2022. (accessed October 20, 2022). 4. AstraZeneca Canada Inc. Evusheld receives Health Canada approval for treatment of COVID-19. October 18, 2022. (accessed October 20, 2022).

Health Canada approves two therapies for COVID-19 treatment

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