Under an expanded Emergency Use Authorization (EUA), remdesivir may now be used to treat all hospitalized adult and pediatric patients with suspected or laboratory-confirmed coronavirus disease 2019 (COVID-19), regardless of disease severity, according to the Food and Drug Administration (FDA).
The Agency broadened the scope of the EUA for the investigational broad spectrum antiviral agent following a review of data that showed all hospitalized COVID-19 patients may potentially benefit from the treatment and that these benefits likely outweigh the known and potential risks. “The data to support today’s action are encouraging,” said FDA Commissioner Stephen M. Hahn, MD. “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.” Previously, the EUA limited use to patients with severe disease.
The EUA was expanded based on data from 2 studies that included patients with mild and moderate COVID-19 disease. In ACTT-1, a double-blind, placebo-controlled study, patients with mild, moderate and severe disease were randomized to receive remdesivir (n=541) or placebo (n=521) plus standard of care. Results showed that the median time to recovery was 10 days for the remdesivir group and 15 days for the placebo group; the odds of clinical improvement at day 15 were also found to be statistically higher in the remdesivir group. Results among patients with mild and moderate disease numerically favored remdesivir as well.
In an open-label study of hospitalized patients with moderate disease, the odds of symptom improvement at day 11 were statistically significantly higher among patients who received 5 days of treatment with remdesivir (n=191) compared with standard of care alone (n=200) (odds ratio [OR] 1.65; 95% CI, 1.09-2.48; P =0.017). While not statistically significant, the odds of improvement in clinical status at day 11 with the 10-day regimen of remdesivir (n=193) were numerically favorable when compared with standard of care alone (OR 1.31; 95% CI, 0.88-1.95; P =0.183).
“As our understanding of the spectrum of [severe acute respiratory syndrome coronavirus 2] infection and the presentations and severity of COVID-19 continues to evolve, these results and the expanded EUA represent a new, important step that streamlines bedside prescribing of remdesivir without having to wait for patients to worsen clinically,” said Francisco Marty, MD, an infectious diseases physician at Brigham and Women’s Hospital, and associate professor of medicine at Harvard Medical School. “These study results show that patients with moderate COVID-19 disease may also benefit from a 5-day treatment course of remdesivir.”
An updated fact sheet for remdesivir providing important information, including dosing, potential side effects, and drug interactions, can be found here.
Gilead, the manufacturer of remdesivir, recently submitted a New Drug Application to the FDA seeking approval of the drug for COVID-19. If approved, the antiviral agent would be marketed under the brand name Veklury®.
For more information visit fda.gov.
- FDA broadens Emergency Use Authorization for Veklury (remdesivir) to include all hospitalized patients for treatment of COVID-19. https://www.fda.gov/news-events/press-announcements/covid-19-update-fda-broadens-emergency-use-authorization-veklury-remdesivir-include-all-hospitalized. Accessed August 30, 2020.
- Gilead’s investigational antiviral Veklury® (remdesivir) receives US Food and Drug Administration Emergency Use Authorization for the treatment of patients with moderate COVID-19. https://www.businesswire.com/news/home/20200828005370/en/Gilead%E2%80%99s-Investigational-Antiviral-Veklury%C2%AE-Remdesivir-Receives-U.S. Accessed August 30, 2020.