Actemra is indicated for the treatment of hospitalised Covid-19 patients who are on systemic corticosteroids, and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation
Roche Canada has received Health Canada authorisation for its antibody therapy Actemra (tocilizumab) to treat Covid-19 in adult patients.
The drug is indicated for hospitalised Covid-19 patients who are on systemic corticosteroids and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation.
The regulatory approval recommends the administration of a single intravenous (IV) infusion of Actemra at 8mg/kg dose, over 60 minutes, to treat adult patients with Covid-19.
Also, the approval contraindicates any dose exceeding 800mg per infusion.
Actemra is the first humanised interleukin-6 receptor-antagonist approved by Health Canada for both subcutaneous and intravenous administration to treat rheumatoid arthritis, said Roche Canada
McMaster University associate professor Zain Chagla said: “Actemra has been a cornerstone for treatment of moderate to severe Covid-19 since multiple large clinical trials have shown a positive benefit.
“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 hospitalised patients with Covid-19.”
The Health Canada approval of Actemra for Covid-19 is based on data from the Phase 3 RECOVERY collaborative group study conducted in the UK.
The randomised, controlled, open-label, multi-centre platform study evaluated the efficacy and safety of potential treatments in adult patients hospitalised with severe Covid-19.
The study participants received usual care and underwent the main randomisation to 0, 1, 2 or 3 additional treatments being investigated for use in the treatment of Covid-19.
The efficacy analyses were based on 4,116 participants who were re-randomised to either tocilizumab plus usual care or usual care alone, with time to death through Day 28 as the primary outcome.
In the study, 31% of patients who received tocilizumab plus usual care and 35% of patients receiving usual care alone died within 28 days.
In addition, Actemra resulted in improved outcomes including mortality in hospitalised patients with Covid-19, who require supplemental oxygen, said the company.