FDA Expand Emergency Use Authorization for Remdesivir

“Continuing to make safe, helpful treatments available” says commissioner 

The FDA expanded remdesivir’s emergency use authorization to allow for all hospitalized COVID-19 patients, regardless of case severity, to be treated with the drug.

The FDA granted emergency use authorization to remdesivir May 1, stipulating that the drug only be used to treat hospitalized COVID-19 patients who are using ventilators or have low blood oxygen levels. The agency’s Aug. 28 announcement broadens the drug’s emergency use authorization to include treatment for all hospitalized COVID-19 patients.

“The data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus,” FDA Commissioner Stephen Hahn, MD, said in a news release. “We are working with drug developers to conduct randomized clinical trials to further study the safety and effectiveness of a number of potential therapies for COVID-19.”

“The FDA continues to make safe and potentially helpful treatments for COVID-19 available as quickly as possible in order to help patients,” FDA Commissioner Stephen Hahn said. “The data to support today’s action are encouraging. The data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus.”

The FDA updated remdesivir’s emergency use authorization based on data from clinical trials comparing recovery times among COVID-19 patients who received the drug against those of patients who received a placebo. One randomized trial sponsored by the National Institute of Allergy and Infectious Diseases found patients in the remdesivir group on average recovered five days sooner than those in the placebo group.

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