Roche announced this Friday that the FDA has issued an Emergency Use Authorization (EUA) for intravenous ‘Actemra’ / ‘RoActemra’ (tocilizumab) for the treatment of covid-19 in hospitalized adults and children (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
The EUA is based on the results of four randomized, controlled studies that evaluated it for the treatment of COVID-19 in more than 5,500 hospitalized patients. Data from these studies suggest that this therapy may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or respiratory support.
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As Dr Levi Garraway, Roche Medical Director and Head of Global Product Development, has pointed out:
The FDA granted EUA based on data from four trials that analysed the safety and efficacy of Actemra in more than 5,500 Covid-19 patients in the hospital.
The RECOVERY study was led by UK researchers and involved more than 4,000 hospitalized covid-19 patients.
Roche-sponsored international trials included the placebo-controlled studies EMPACTA, COVACTA and REMDACTA.
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