FDA Authorizes Drug for Treatment of COVID-19
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug Actemra (tocilizumab) for the treatment of hospitalized adults and pediatric patients (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). Actemra is not authorized for use in outpatients with COVID-19.
In clinical trials of hospitalized patients with COVID-19, Actemra in addition to the routine care patients receive for treatment of COVID-19, which included corticosteroid therapy, was shown to reduce the risk of death through 28 days of follow-up and decrease the amount of time patients remained hospitalized. The risk of patients being placed on ventilators or death through 28 days of follow-up was also decreased.
Under the EUA, fact sheets that provide important information about using Actemra in treating COVID-19 as authorized must be made available to health care providers and to patients, parents, and caregivers. These fact sheets include dosing instructions, potential side effects and drug interactions. Common side effects of Actemra observed in the COVID-19 trials include constipation, anxiety, diarrhea, insomnia, hypertension and nausea.
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