FDA issues emergency use authorization for remdesivir

May 4, 2020

The U.S. Food and Drug Administration (FDA) 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, the agency announced in a press release.

While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, a clinical trial of the investigational drug showed that hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received a placebo.

The trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19.

Remdesivir, developed by Gilead Sciences, is a broad-spectrum antiviral treatment administered via daily infusion for 10 days, according to the NIH.

The EUA allows healthcare providers to treat suspected or laboratory-confirmed cases of COVID-19 in adults and children hospitalized with severe disease, which the FDA defines as patients with low blood oxygen levels or who need oxygen therapy or more intensive breathing support such as a mechanical ventilator.

In a letter on the company’s website, Gilead Sciences President and CEO Daniel O’Day, said, “Our existing supply, including finished product ready for distribution, as well as materials in the final stages of production, amounts to 1.5 million individual doses.”

In describing its decision, FDA said in the news release, “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 FDA said 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.

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