The FDA notified Gilead Sciences in a letter dated May 1 that it has granted Emergency Use Authorization (EUA) for remdesivir, an antiviral drug reportedly shown to decrease the time to recovery for some COVID-19 patients. FDA based its approval on three criteria, including: the potential severity of COVID-19, the base of evidence for the safety and efficacy of remdesivir, and the lack of alternatives for treating patients with COVID-19. The drug will be made available to hospitalized COVID-19 patients and administered intravenously for up to 10 days. FDA advised in a fact sheet for patients that remdesivir has not been extensively studied and the full scope of its potential side effects remains unknown, though patients may experience “infusion-related reactions,” such as low blood pressure and nausea. Elevated levels of liver enzymes have also occurred, according to FDA.
Two clinical trials were conducted to investigate the impact of remdesivir on recovery from COVID-19. One study, conducted by the National Institutes of Health, was a randomized, controlled trial with 1,063 participants. In that study, patients who took remdesivir recovered from COVID-19 four days faster than patients who received a placebo, and mortality among the treatment group was lower (8% versus 11.6% in the placebo group). The second study, conducted by remdesivir manufacturer Gilead Sciences, involved 397 patients and did not include a placebo arm. Gilead reported that half of the patients who took remdesivir showed improvement in 10-11 days.
The EUA is not permanent and was enabled by a special declaration of the Department of Health and Human Services because of the circumstances presented by the COVID-19 pandemic. The drug has not been reviewed in the manner normally required for FDA approval.
Sources:
https://www.fda.gov/media/137564/download
https://www.fda.gov/media/137565/download
http://med.stanford.edu/news/all-news/2020/05/remdesivir-approved-by-fda-for-covid-19.html
https://www.nih.gov/news-events/news-releases/nih-clinical-trial-shows-remdesivir-accelerates-recovery-advanced-covid-19
https://www.gilead.com/news-and-press/press-room/press-releases/2020/4/gilead-announces-results-from-phase-3-trial-of-investigational-antiviral-remdesivir-in-patients-with-severe-covid-19