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FDA approves first COVID-19 treatment

Kate Rockwood writer headshot By | October 27, 2020
Medically reviewed by Marissa Walsh, Pharm.D., BCPS-AQ ID

CORONAVIRUS UPDATE: As experts learn more about the novel coronavirus, news and information changes. For the latest on the COVID-19 pandemic, please visit the Centers for Disease Control and Prevention.

The U.S. Food and Drug Administration (FDA) approved the first targeted COVID-19 treatment, Veklury (remdesivir), on Oct. 22. The drug from Gilead Sciences, Inc. can now be used for anyone ages 12 and older who weigh at least 40 kilograms (roughly 88 pounds) and is hospitalized with the novel coronavirus.

Remdesivir coronavirus results 

The approval was based on the FDA’s analysis of three randomized, controlled clinical experiments of hospitalized adult patients with mild to severe COVID-19. The studies found that treatment with the drug produced clinical improvements across several outcomes, including a faster time to recovery and reduced disease progression, as well as a trend toward reduced mortality, in comparison to placebo.

“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, MD in a statement. “[This] 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.” 

The antiviral treatment was given emergency use authorization in May, and can still be used in that capacity for patients younger than 12 years old and weighing at least 3.5 kilograms (roughly 8 pounds). Clinical trials on the safety and efficacy of the drug in children younger than 12 are still ongoing.

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What is Veklury and how does it work?

Veklury is an antiviral treatment delivered intravenously as an infusion and works by limiting how well SARS-CoV-2, the virus that causes COVID-19, can make copies of itself. The drug isn’t a vaccine or a cure. It’s intended to help people with COVID-19 recover more quickly.

Before receiving Veklury, patients will undergo certain blood tests to evaluate their liver and kidney function to make sure they can safely be treated with the drug. This organ function will also be monitored throughout the treatment course. That’s partly because one of the potential side effects of Veklury is increased liver enzymes, a potential sign of liver injury. Other possible side effects include hypersensitivity reactions presenting as low blood oxygen level, fever, wheezing, swelling, shortness of breath, sweating or shivering, according to the FDA. 

How much does Veklury cost?

Gilead currently charges $2,340 for a five-day treatment for people with government-based health insurance and $3,120 for people with private health insurance. It’s available to hospitals and healthcare facilities that treat COVID-19 patients.