Remdesivir became the first drug to receive FDA approval for COVID-19 treatment

On October 22, 2020, the US Food and Drug Administration (FDA) approved remdesivir, the active ingredient in Veklury, as a treatment for people aged 12 and older who are hospitalized with COVID-19. Remdesivir became the first and only FDA-approved treatment for COVID-19. This approval also brought considerable controversy. 

The FDA's initial Emergency Use Authorization (EUA) for this antiviral drug, issued in May, allowed its use only in patients with severe COVID-19 (particularly those with low blood oxygen levels who needed oxygen therapy or mechanical ventilation).

In August, this Emergency Use Authorization for remdesivir was expanded to cover all hospitalized adult and pediatric COVID-19 patients, regardless of the severity of their illness. On October 22, the FDA also issued a new EUA for remdesivir permitting treatment of hospitalized pediatric patients younger than 12 years who weigh at least 3.5 kg.

According to remdesivir's developer, Gilead, today's approval is based on three randomized controlled clinical trials.

Final study results published earlier in October, including the ACTT-1 study funded by the National Institute of Allergy and Infectious Diseases (NIAID), showed that hospitalized COVID-19 patients receiving remdesivir had a shorter median recovery time than those receiving placebo (10 days versus 15 days).

This difference and some related secondary endpoints were statistically significant in the randomized trial, but there was no statistically significant difference in mortality between the treatment and placebo groups.

The other two trials used for approval, the SIMPLE trials, were open-label phase 3 trials conducted in countries with high rates of COVID-19 infection, according to Gilead.

SIMPLE-Severe is a randomized, multicenter study evaluating the efficacy and safety of 5-day and 10-day dosing alongside standard care in 397 hospitalized adult patients with severe COVID-19. According to Gilead, the primary endpoint was the patient's clinical status assessed on day 14.

The study found that a 5-day or 10-day course of Veklury achieved clinical outcomes similar to the ACTT-1 study.

According to Gilead's release, SIMPLE-Moderate is a randomized, controlled, multicenter study evaluating the efficacy and safety of 5-day and 10-day dosing periods of Veklury added to standard care, compared with standard care alone, in 600 hospitalized adult patients with moderate COVID-19.

The primary endpoint was clinical status on day 11. According to Gilead, the results showed statistically improved clinical outcomes with a 5-day course of Veklury compared with standard care.

At the beginning of this article, we emphasized that this FDA approval led to considerable controversy. Exactly 1 week before the approval, on October 15, a comprehensive clinical trial sponsored by the World Health Organization (WHO) involving 11 thousand patients released its results, which had shown that remdesivir was not effective in treating COVID-19. Because of this contradictory situation, widespread use of remdesivir around the world may not be possible, and its use may remain limited to the United States.

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