FDA Grants EUA to Roche’s Tocilizumab Despite Mixed Study Results

FDA Grants EUA to Roche’s Tocilizumab Despite Mixed Study Results

The U.S. Food and Drug Administration (FDA) made yet another questionable decision by issuing an emergency use authorization (EUA) for Roche’s IL-6 inhibitor called Actemra/RoActemra (tocilizumab) for the treatment of COVID-19 in hospitalized adults and pediatric patients (two years of age and up) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygen (ECMO). Roche declared that the EUA was based on the results from four randomized, controlled trials that evaluated the drug for the treatment of COVID-19 in over 5,500 hospitalized patients. The multinational pharmaceutical company headquartered in Basal, Switzerland, indicated that the result of these studies suggests that this drug “may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.” As TrialSite will discuss below, the study results are mixed at best. But the use of the four studies mentioned (RECOVERY, EMPACTA, COVACTA, and REMDACTA) led to FDA positive decisions leading to the EUA. As some of these studies generated questionable results, the FDA’s decision to acc...

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