KUWAIT, Aug 29: The US Food and Drug Administration (FDA) announced that it has “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 “as part of its ongoing efforts to fight COVID-19.”
“Based on the Agency’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 said in a statement on Saturday.
It added that the Agency’s review has also concluded that “the known and potential benefits of Veklury outweigh the known and potential risks for these uses.”
FDA Commissioner Stephen Hahn said in this regard that the FDA “continues to make safe and potentially helpful treatments for COVID-19 available as quickly as possible in order to help patients.”
“The data to support today’s action are encouraging. The data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus,” he affirmed.
He continued “we are working with drug developers to conduct randomized clinical trials to further study the safety and effectiveness of a number of potential therapies for COVID-19.”
In May, the FDA issued an EUA that authorized Veklury for the treatment of hospitalized adult and pediatric patients with “severe” COVID-19.
This comes as the confirmed coronavirus cases nationwide topped 5.9 million and at least 182,069 deaths. (KUNA)