The Food and Drug Administration (FDA) has approved the use of Veklury (remdesivir) for use in adult and adolescent patients 12 years of age and older for the treatment of COVID-19 in instances that require hospitalization. The drug is the first approved treatment for COVID-19, and use is limited to hospitals and other healthcare settings approved to provide inpatient care as reported by World Pharma News. The approval for patients over the age of 12 is distinct from the Emergency Use Authorization (EUA) approval for the drug in May.
The approval of Veklury was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19.
"The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency," said FDA Commissioner Stephen M. Hahn, M.D. "Today's approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic.[…]”
One randomized, double-blind, placebo-controlled clinical trial (ACTT-1) evaluated how long it took for subjects to recover from COVID-19 within 29 days of being treated. The median time to recovery from COVID-19 was 10 days for the Veklury group compared to 15 days for the placebo group.
A second randomized, open-label multi-center trial found the odds of a subject’s COVID-19 symptoms statistically improved in the Veklury group when compared to those receiving only standard of care.
A third trial used in the FDA’s evaluation compared treatment with Veklury for five days and ten days in adult patients with severe COVID-19. Overall, the odds of a subject’s COVID-19 symptoms improving were similar for those in the five-day Veklury group as those in the 10-day Veklury group, and there were no statistically significant differences in recovery rates or mortality rates between the two groups.
The approval included information for clinicians including usage instructions, dosing, and side effects. Possible side effects of the drug include increased levels of liver enzymes, allergic reactions, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering.