The Food and Drug Administration (FDA) has expanded the approval of Veklury® (remdesivir; Gilead Sciences) to include treatment of COVID-19 in nonhospitalized patients aged 12 years and older (weighing at least 40kg) with mild to moderate disease who are at high risk for progression to severe disease, including hospitalization and death. Previously, the treatment had only been approved for hospitalized patients.
Veklury is a nucleotide analogue with broad spectrum antiviral activity. The expanded approval allows for use of the drug in outpatient settings that can administer daily intravenous (IV) infusions over 3 consecutive days.
The FDA has also updated the pediatric Emergency Use Authorization (EUA) for Veklury to include nonhospitalized pediatric patients weighing 3.5kg to less than 40kg or pediatric patients less than 12 years of age weighing at least 3.5kg, with positive results of direct SARS-CoV-2 viral testing, who have mild to moderate COVID-19, and are at high risk for progression to severe disease, including hospitalization or death.
The new recommendations are based on data from the phase 3 PINETREE study (ClinicalTrials.gov Identifier: NCT04501952), which evaluated the safety and efficacy of remdesivir administration in an outpatient setting (N=562).
Findings showed that among nonhospitalized patients at high risk for COVID-19 disease progression, treatment with remdesivir reduced the risk of hospitalization or death by 87% compared with placebo (hazard ratio, 0.13; 95% CI, 0.03-0.59; P =.008).
By day 28, hospitalization or death from any cause (composite primary endpoint) occurred in 2 of the 279 patients in the remdesivir arm (0.7%) and 15 of the 283 patients in the placebo arm (5.3%); no deaths were reported in either group.
Data from the PINETREE study also supported the recently added recommendation of remdesivir for treatment of COVID-19 in nonhospitalized settings in the National Institutes of Health Treatment Guidelines for COVID-19.
“On the heels of the FDA’s recent authorization of 2 oral antiviral drugs, today’s actions bolster the arsenal of therapeutics to treat COVID-19 and respond to the surge of the Omicron variant,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research. “Today’s actions provide adults and pediatric patients, with mild to moderate COVID-19 who are at high risk of severe COVID-19, with a treatment option they could receive outside of a traditional inpatient hospital setting, including at skilled nursing facilities, home healthcare settings and outpatient facilities such as infusion centers.”
- FDA takes actions to expand use of treatment for outpatients with mild to moderate COVID-19. News release. January 21, 2022. https://www.prnewswire.com/news-releases/fda-takes-actions-to-expand-use-of-treatment-for-outpatients-with-mild-to-moderate-covid-19-301466070.html
- FDA approves Veklury® (remdesivir) for the treatment of nonhospitalized patients at high risk for COVID-19 disease progression. News release. January 21, 2022. https://www.businesswire.com/news/home/20220121005359/en/FDA-Approves-Veklury%C2%AE-Remdesivir-for-the-Treatment-of-Non-Hospitalized-Patients-at-High-Risk-for-COVID-19-Disease-Progression
- Gottlieb RL, Vaca CE, et al. Early remdesivir to prevent progression to severe COVID-19 in outpatients. Published online December 22, 2021. New England Journal of Medicine. doi: 10.1056/NEJMoa2116846