FDA Broadens Emergency Use Authorization for Veklury (remdes
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U.S. Food and Drug Administration broadened the scope of the existing emergency use authorization (EUA) for the drug Veklury (remdesivir) to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.

In May 2020, the FDA issued an EUA that authorized Veklury for the treatment of hospitalized adult and pediatric patients with severe COVID-19, which was defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.

Based on the Agency’s ongoing review of the EUA, FDA determined that it is reasonable to believe Veklury may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients.

The review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses.

The expansion of the scope of the EUA to include hospitalized patients with mild or moderate COVID-19 is supported by the Agency’s analysis of additional data from two randomized, controlled clinical trials that included patients with mild or moderate disease.

Possible side effects include: increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating, and shivering.ring.

Source: https://www.fda.gov/news-events/press-announcements/covid-19-update-fda-broadens-emergency-use-authorization-veklury-remdesivir-include-all-hospitalized
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