Last week, the Food and Drug Administration (FDA) broadened the scope of the existing emergency use authorization (EUA) for Veklury (remdesivir; Gilead Sciences Inc.).
Veklury is now authorized for the treatment of all hospitalized adult and pediatric patients with suspected or laboratory confirmed COVID-19, regardless of their severity of disease. Based on the FDA’s ongoing review of the EUA, including its review of the totality of scientific information now available, the FDA has 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 FDA’s review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses.
The EUA authority allows the FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear threats by facilitating the availability and use of medical countermeasures needed during public health emergencies.
Food and Drug Administration (FDA). COVID-19 Update: FDA Broadens Emergency Use Authorization for Veklury (remdesivir) to Include All Hospitalized Patients for Treatment of COVID-19 [news release]. August 28, 2020. Available at: click here. Accessed September 1, 2020.