The U.S. Food and Drug Administration (FDA) has approved remdesivir (Veklury) for the treatment of COVID-19 infection, Gilead Sciences said Thursday.
Headquartered in Foster City, California, Gilead is the manufacturer of remdesivir, the antiviral drug that was initially developed for Ebola treatment. However, the drug has been found effective at treating COVID-19.
Veklury is the first FDA-approved drug for COVID-19 infection. Remdesivir has been under FDA’s emergency use authorization since May.
In a statement, Gilead said, “In the United States, Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization.”
“Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care,” the company added.
Earlier this month, a global study funded by the World Health Organization (WHO) found remdesivir ineffective at helping patients to survive or even recover faster. However, a US study found that the drug shortened recovery time for some hospitalized COVID-19 patients.
Gilead submitted a study published in the New England Journal of Medicine (NEJM) to the FDA, which showed remdesivir effective at shortening the course of illness from 15 days to about 11 days in hospitalized COVID-19 patients.
The FDA also took two other studies into consideration, with one showing a slight benefit on using remdesivir and another showing the drug did not make much difference.
Dr. Rick Bright, former head of the Biomedical Advanced Research and Development Authority (BARDA), said he was personally not impressed by remdesivir.
“It’s important to note that even the data that we saw in the United States from that drug show that the benefit was modest,” Dr. Bright told CNN. “It wasn’t a home run. It wasn’t a remarkable improvement in terms of mortality, or even the lengthening or shortening of the length of hospital stay, but it did show some marginal benefit.”
FDA Commissioner Dr. Stephen Hahn said in a statement, “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.” “As part of the FDA’s Coronavirus Treatment Acceleration Program,” he added, “the agency will continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”
