APhA coronavirus watch: FDA authorizes emergency use of remdesivir for patients with severe COVID-19 infection

On May 1, 2020, FDA issued an emergency use authorization (EUA) to Gilead for the investigational antiviral drug remdesivir to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. According to the agency, while there is limited information known about remdesivir’s safety and effectiveness to treat people in the hospital with COVID-19, the drug was shown in a clinical trial to shorten the time to recovery in some patients.

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. Patients with severe disease have low blood oxygen levels or need oxygen therapy or more intensive breathing support, such as a mechanical ventilator.

Issuance of an EUA is different from an FDA approval. In determining whether to issue an EUA, the agency 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.

On this basis, the agency 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 drug’s known and potential risks.

The EUA also requires that fact sheets that provide important information about using remdesivir in treating COVID-19 be made available to health care providers and patients, including dosing instructions, potential adverse effects, and drug interactions. Possible adverse effects 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.