FDA Issues Emergency Use Authorization for Remdesivir in COVID-19

Officials with the FDA have issued an emergency use authorization (EUA) for remdesivir (Gilead Sciences) for the treatment of suspected or laboratory-confirmed coronavirus disease 2019 (COVID-19) in hospitalized adults and children, according to a press release.¹

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, the agency said.¹

Evaluation of EUA criteria and scientific evidence indicate that remdesivir may be effective in treating the virus, for which there are currently no FDA-approved therapies. According to the FDA, “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.”¹

Severe disease is defined as patients with an oxygen saturation ≤94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation.²

“From day 1, the FDA has been committed to expediting the development and availability of potential COVID-19 treatments,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.¹ “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.”

This past week, Gilead and the National Institutes of Health (NIH) announced new data from studies evaluating remdesivir for use in patients with severe COVID-19. The NIH study indicated that hospitalized patients with severe infection and lung involvement who received remdesivir recover faster than similar patients, with a 31% faster time to recovery than those who received placebo.³

Recently released data from the phase 3 SIMPLE trial showed that 10-day treatment with remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course. The results showed that time to clinical improvement for 50% of patients was 10 days in the 5-day treatment group and 11 days in the 10-day treatment group, according to the study. Full data were not released, but Gilead said it plans to submit the results for publication in the coming weeks.³

However, a study published in the Lancet this week suggested that remdesivir did not demonstrate efficacy in hospitalized patients with COVID-19. The investigators of the study noted that the trial was stopped early due to difficulty enrolling new patients and warned that interpretation of the findings is limited.³

Read more about the new clinical data on remdesivir in COVID-19 here.

The FDA has made a fact sheet available for health care providers, including dosing instructions, potential adverse effects, and drug interactions.²

References:

1. Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment. News Release. FDA; May 1, 2020. Accessed May 1, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-potential-covid-19-treatment.

2. Fact Sheet for Health Care Providers Emergency Use Authorization (EUA) of Remdesivir (GS-5734). News Release. FDA; May 1, 2020. Accessed May 1, 2020.  https://www.fda.gov/media/137566/download

3. Barrett J. Clinical Trial Updates: Early Data on Remdesivir for Severe COVID-19. Drug Topics; Published April 29, 2020. Accessed May 1, 2020. https://www.drugtopics.com/coronavirus/clinical-trial-updates-early-data-remdesivir-severe-covid-19