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.
