On Thursday, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) in adult and pediatric patients for the treatment of COVID-19.

Remdesivir is the first treatment for COVID-19 to receive FDA approval. To receive the treatment patients must be 12 years of age and older and weighing at least about 88 pounds. The FDA states that remdesivir should only be administered in a hospital or healthcare setting capable of providing impatient care.

Developed at UNC in partnership with Gilead, the drug’s manufacturer, remdesivir has now been approved or authorized for temporary use as a COVID-19 treatment in approximately 50 countries worldwide.

FDA Commissioner Dr. Stephen Hahn said the FDA has been continuously working to bring new COVID-19 treatments to the public as quickly and safely as possible.

“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” Hahn said. “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.”

According to the FDA, under the Federal Food, Drug, and Cosmetic Act, approval of a new drug product requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). When approving a drug, the FDA conducts a “benefit-risk assessment” to ensure that the product’s benefits outweigh its risks for the intended population. The approval of remdesivir 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.

At the beginning of October, President Trump was diagnosed with COVID and treated with a combination of three different therapeutics, including remdesivir.

Dr. David Wohl is a professor of medicine at UNC and an infectious disease expert. He said of the three therapeutics used to treat the president, including Dexamethasone and a Regeneron cocktail of monoclonal antibodies, remdesivir is the most widely used.

“Remdesivir is an antiviral drug that’s administered intravenously for five days,” Wohl said. “We use this all the time. It’s standard of care here [at UNC] and across the U.S.”

According to the National Institutes of Health, remdesivir is an antiviral medication that targets a range of viruses. It was originally developed over a decade ago to treat hepatitis C and a cold-like virus called respiratory syncytial virus (RSV). Remdesivir wasn’t an effective treatment for either disease, but it showed promise against other viruses.

Remdesivir works by interrupting production of the virus. Coronaviruses have genomes made up of ribonucleic acid (RNA). Remdesivir interferes with one of the key enzymes the virus needs to replicate RNA. This prevents the virus from multiplying.

Lead photo courtesy of UNC. 

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