Roche’s Actemra IV (tocilizumab) Receives Health Canada Authorization for Additional Indication to Treat COVID-19

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Health Canada has granted authorization for Actemra IV in hospitalized adult patients with COVID-19
The approval was based on P-III results from the (RECOVERY) trial evaluating Actemra IV in the UK. Eligible patients (n=21 550) were given standard care before being randomly assigned to 0, 1, 2, or 3 additional COVID-19 treatments while Actemra is administered as a single IV infusion of 8mg/kg over 60min.
The primary outcome was time to death through Day 28, 31% randomized to tocilizumab + usual care vs 35% to usual care alone died within 28 days; median time to hospital discharge was 19 vs >28 days; patients who required mechanical ventilation or died by Day 28 (35% vs 42%)

Ref: Newswire | Image: Roche