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:
Even with the availability of vaccines and declines in deaths from Covid-19 in various parts of the world, we continue to see new hospitalisations from severe forms of the disease.
We are pleased that Actemra is now authorised as an option that may help improve outcomes for adults and children hospitalised with Covid-19 in the United States.
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.
Photo by Jason Armond / Los Angeles Times via Getty Images
