FDA approves first COVID-19 drug: the antiviral remdesivir

Study shows drug reduces COVID-19 recovery time

FILE - In this March 2020 photo provided by Gilead Sciences, rubber stoppers are placed onto filled vials of the investigational drug remdesivir at a Gilead manufacturing site in the United States. Given through an IV, the medication is designed to interfere with an enzyme that reproduces viral genetic material. (Gilead Sciences via AP) (Uncredited, Gilead Sciences)

The U.S. Food and Drug Administration has approved the first drug to treat COVID-19: remdesivir, an antiviral medicine given through an IV for patients needing hospitalization.

The drug, which California-based Gilead Sciences Inc. is calling Veklury, cut the time to recovery by five days — from 15 days to 10 on average — in a large study led by the U.S. National Institutes of Health.

It had been authorized for use on an emergency basis since spring, and now has become the first drug to win full U.S. approval for treating COVID-19.

Gilead says Veklury is approved for people at least 12 years old and weighing at least 88 pounds (40 kilograms) who need hospitalization for their coronavirus infection. It works by inhibiting a substance the virus uses to make copies of itself.

The FDA previously issued an emergency use authorization for the drug in May for the treatment of hospitalized COVID-19 patients with severe infections. In August, the FDA reduced restrictions of drug usage, allowing COVID-19 patients without severe infections to be treated with the drug.

The FDA’s approval on Thursday of the a New Drug Application (NDA) for remdesivir means that the administration believes the drug is safe and effective for its intended use based on evidence from early testing, preclinical and clinical trials.

The news comes as COVID-19 cases are on the rise throughout the U.S. -- including in Michigan.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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