FDA authorizes first COVID-19 treatment
The U.S. Food and Drug Administration (FDA) issued an emergency authorization on Friday evening for the investigational antiviral drug remdesivir for the treatment of the novel coronavirus (COVID-19), according to a statement released by the agency.
According to the FDA, while there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was shown in a clinical trial to shorten the time to recovery in some patients.
The emergency use authorization, issued to Gilead Sciences Inc., expands on a previous authorization allowing the company to investigate the drug in clinical trial and permits for remdesivir to be distributed in the U.S. and administered intravenously by healthcare providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator, the agency said.
Based on evaluation of the emergency use authorization criteria and the scientific evidence available, the FDA said it 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 authorization requires that fact sheets that provide important information about using remdesivir in treating COVID-19 be made available to healthcare providers and patients, including dosing instructions, potential side effects, and drug interactions. Possible side effects of remdesivir 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.
The FDA said it may issue an emergency use authorization to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological and nuclear threats when there are no adequate, approved, and available alternatives.
The emergency use authorization is different from FDA approval, the agency said. When determining whether to issue an authorization, the FDA said it evaluates the available evidence and carefully balances any known or potential risks of any unproven products with any known or potential benefits of making them available during the emergency.
The agency said the authorization will be effective until circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated and may be revised or revoked if it is determined the authorization is no longer meets the statutory criteria for issuance.