The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as low blood oxygen levels or requirement of oxygen therapy or more intensive breathing support, such as a mechanical ventilator.
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] FDA’s emergency authorization of remdesivir, 2 days after the National Institutes of Health’s clinical trial showed promising results, is a significant step forward in battling COVID-19,” said Department of Health and Human Services Secretary Alex Azar.
The EUA allows for remdesivir to be distributed in the United States and administered intravenously by health-care providers as appropriate to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.
Stephen M. Hahn, MD
“From day one, the FDA has been committed to expediting the development and availability of potential COVID-19 treatments. [This] 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. “There’s tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19, and through our Coronavirus Treatment Acceleration Program, the FDA is working around-the-clock and using every tool at our disposal to speed these efforts.”
More About the EUA
Based on evaluation of the EUA 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 also requires that fact sheets providing important information about using remdesivir in the management of COVID-19 be made available to health-care 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 previously allowed for study of the investigational drug under clinical trials, as well as expanded access use for individual patients and through a multipatient expanded access program coordinated by Gilead, the manufacturer. The EUA will be effective until the declaration that 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 EUA no longer meets the statutory criteria for issuance.