As part of its ongoing efforts to fight COVID-19, the U.S. Food and Drug Administration today 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. As noted in the initial issuance of the EUA, the emergency use of Veklury was limited to those patients with severe disease, which was defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.
Today, 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 Agency’s review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses.
“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,” said FDA Commissioner Stephen M. Hahn, M.D. “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.”
Read more at FDA
- Influenza and serious heart conditions link is strong: Study
- Eastern Equine Encephalitis: 11 horses in 8 counties since July
- South Carolina: Bobcat tests positive for rabies in Marion
- Malaria transmission patterns could emerge due to climate change: Study
- COVID-19 Study: Children and teenagers are less likely than adults to develop severe disease or die
- CRISPR-based tests detects Lassa and Ebola in real-time
- People with antibodies to Zika virus are more vulnerable to severe infection with certain types of dengue
- COVID-19 antigen test receives EUA, Similar in design to some pregnancy tests