FDA Approves the First Treatment for COVID-19

On October 22, the Food and Drug Administration (FDA) approved remdesivir to treat COVID-19, making it the first and only COVID-19 treatment to have received full federal approval. 

While the drug’s developer, Gilead Sciences, was granted an emergency use authorization (EUA) for remdesivir at the beginning of May, federal approval requires additional evidence to support safety and efficacy. 

Remdesivir is now approved for patients over the age of twelve who are hospitalized with COVID-19. The drug is administered intravenously, typically for five days. Gilead will sell the drug under its brand name, Veklury. 

Remdesivir is an antiviral drug initially developed as a treatment for the Ebola virus and hepatitis C. The drug works by interfering with the reproduction of viral genes. 

A clinical trial funded by the National Institutes of Health found that remdesivir reduced the length of hospital stays among patients with moderate symptoms from fifteen days to just eleven. President Trump received remdesivir after showing symptoms earlier this month. 

However, remdesivir has not yet been shown to have a significant effect on the mortality rate of COVID-19. The World Health Organization (WHO) recently reported preliminary data indicating that the drug did not benefit patients with severe symptoms. 

Many infectious disease experts believe antivirals like remdesivir work best when administered early. Severe COVID-19 is thought to be driven primarily by an overly forceful immune response—an antiviral like remdesivir may act as a buffer against such an overreaction. 



Since its EUA in May, remdesivir has been administered to thousands of patients across the country. For patients with private insurance, the drug costs $3,120 per treatment course. 

The clinical trial led by the WHO found that remdesivir had little to no effect on the duration of any given patient’s hospital stay or their chances of survival. 

The “solidarity” trial evaluated the effects of four potential drug regimens side-by-side, including remdesivir, hydroxychloroquine, anti-HIV drug combination lopinavir/ritonavir, and interferon. 

The trial included 11,266 adult COVID-19 patients across more than thirty countries. While hydroxychloroquine and lopinavir/ritonavir trials ceased in June after proving ineffective, other trials continued in more than 500 hospitals. 

The WHO reported that drug regimens appeared to have little to no effect on 28-day mortality rates or the length of hospital stays. 

While the trial appears to offer a global perspective, many infectious disease experts have criticized its open-label design and lack of uniformity. Failing to include a placebo group and allowing both patients and doctors to know which treatment is being administered can skew results. 

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Are you interested in keeping your organization COVID-ready? Get in touch with a member of the CfPIE team by calling 1-610-648-7550 or emailing [email protected].