The US FDA took two actions to expand remdesivir access (Veklury, Gilead Sciences Inc) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease. Previously, the use of remdesivir was limited to patients requiring hospitalization.
The FDA has expanded remdesivir access to include its use in adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms, which is about 88 pounds) with positive results of direct SARS-CoV-2 viral testing, and who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.
The agency also revised the Emergency Use Authorization (EUA) for remdesivir to additionally authorize the drug for treatment of pediatric patients weighing 3.5 kilograms to less than 40 kilograms or pediatric patients less than 12 years of age weighing at least 3.5 kilograms, with positive results of direct SARS-CoV-2 viral testing, and who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization of death.
Based on today’s actions, these high-risk non-hospitalized patients may receive remdesivir via intravenous infusion for a total of three days for the treatment of mild-to-moderate COVID-19 disease.
Pediatric patients for whom remdesivir is authorized will receive doses adjusted for their body weight in order to achieve comparable exposures to adults and pediatric patients receiving the approved dose. Given the similar course of COVID-19 disease, the authorization of remdesivir in certain pediatric patients is based on extrapolation of efficacy from adequate and well-controlled studies in adults.
“On the heels of the FDA’s recent authorization of two 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.”