COVID-19 Resource Center

COVID-19 Resource Center

May 01, 2020
1 min read

FDA authorizes emergency use of remdesivir for COVID-19

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The FDA issued emergency use authorization for remdesivir to be distributed in the United States and administered intravenously by health care providers in adults and children hospitalized with severe cases of confirmed COVID-19.

This announcement follows recent data from a NIH clinical trial that showed Gilead’s investigational antiviral drug had a significant positive effect in reducing recovery time compared with placebo among patients with COVID-19.

“Because preliminary results by the [NIH] suggested that remdesivir may possibly help very sick patients, FDA is allowing this drug to be provided to hospitalized patients with severe COVID-19 under an EUA,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said on Twitter. “An EUA is not the same as FDA approval. Under the EUA, health care providers and patients are provided with information about the risks of remdesivir. We need final data from clinical trials included in an FDA application to determine whether remdesivir is safe and effective in treating or preventing COVID-19.”

The emergency use authorization (EUA) also requires fact sheets with information about remdesivir use for COVID-19 treatment be made available to health care providers and patients. The sheets must include dosing instructions, drug interactions and potential side effects. Known side effects are increased levels of liver enzymes and infusion-related reactions such as low blood pressure, nausea, vomiting, sweating and shivering.

“From day one, the FDA has been committed to expediting the development and availability of potential COVID-19 treatments,” FDA Commissioner Stephen M. Hahn, MD, said in an agency press release. “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.”

The FDA noted that the EUA will be in effect 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.”