The U.S. Food & Drug Administration (FDA) approved the use of the antiviral drug Veklury (generic form Remdesivir) for non-hospitalized patients with COVID-19, marking the first time the antiviral drug has been approved for the treatment of the disease for patients not requiring hospitalization.
The FDA announcement on Jan. 21 comes on the heels of the agency’s recent authorization of two oral antiviral drugs for Covid.
“Today’s actions bolster the arsenal of therapeutics to treat COVID-19 and respond to the surge of the omicron variant,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.
Dr. Cavazzoni added that the FDA approval “Provides 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.”
With the approval, Veklury, which is administered via intravenous infusion for up to three days, is now indicated for use in adults and children 12 years of age or older who weigh at least 88 pounds. The drug is intended for those who have tested positive for COVID-19 and have mild-to-moderate symptoms. This subset of patients must not be hospitalized and be at high risk for progression to severe COVID-19, including hospitalization or death, the FDA announcement states.
The Emergency Use Authorization (EUA) for Veklury was also revised. The drug is now authorized for COVID-positive pediatric patients weighing between approximately 7.7 pounds and 88 pounds, or for patients less than 12 years of age who weigh at least 7.7 pounds who are not hospitalized yet are at risk for developing severe COVID-19 without treatment.
Veklury’s approval for non-hospitalized patients, according to the FDA, was based on a clinical trial. The randomized, placebo-controlled study included 562 non-hospitalized patients with mild-to-moderate COVID-19. The subjects were at high risk for progression to severe COVID-19, including hospitalization or death. Only two of 279 patients who received Veklury required COVID-19-related hospitalization. In the placebo group, 15 of 283 required hospitalization. No deaths were reported in either group.
Children who receive Veklury will receive a smaller dose to adjust for their body weight.
Possible side effects of Veklury include increased levels of liver enzymes, allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling of the lips, around eyes, or under the skin, rash, nausea, sweating, and shivering.