FDA issues EUA for potential COVID-19 treatment

FDA on Friday issued an emergency use authorization (EUA) for remdesivir (Gilead Sciences) for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. The investigational antiviral drug was shown in a clinical trial to reduce the time to recovery in some patients.

FDA on Friday issued an emergency use authorization (EUA) for remdesivir (Gilead Sciences) for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. The investigational antiviral drug was shown in a clinical trial to reduce the time to recovery in some patients. Under the EUA, remdesivir can be distributed in the United States and administered intravenously by health care providers, as appropriate, to treat severe disease. According to FDA, severe disease indicates patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator. The agency noted, "Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug's use." The EUA requires that fact sheets with important information about using remdesivir in treating COVID-19 be made available to health care providers and patients, including dosing information, potential adverse effects, and drug interactions. "Today's action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective," said FDA Commissioner Stephen M. Hahn, MD.