Remdesivir Becomes First FDA-approved Drug for COVID-19 Treatment

The US Food and Drug Administration (FDA) approved the antiviral drug remdesivir (Veklury®, Gilead Sciences Inc.) for the treatment of coronavirus disease 2019 (COVID-19), making it the first FDA-approved treatment for the novel disease.

Remdesivir is indicated for use in adult and pediatric patients aged ≥12 years who weigh at least 40 kg for the treatment of COVID-19 requiring hospitalization. Remdesivir should only be administered in a hospital or health care setting capable of providing acute care comparable to inpatient hospital care.

In addition to the approval, the FDA revised the emergency use authorization (EUA) that was originally issued on May 1, 2020 to authorize the use of remdesivir to treat hospitalized pediatric patients weighing between 3.5-40 kg or hospitalized pediatric patients aged <12 years weighing at least 3.5 kg.

“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 an October 22, 2020 press release. “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.”

The first study, ACTT-1, was conducted by the National Institute of Allergy and Infectious Diseases and evaluated how long it took hospitalized adults with mild, moderate, or severe COVID-19 to recover within 29 days of treatment. Results showed that the median time to recovery was 10 days for those who received remdesivir vs 15 days for those who received placebo, a statistically significant difference.

The other 2 studies, SIMPLE-Severe and SIMPLE-Moderate, examined the use of remdesivir in adult patients with severe and moderate COVID-19, respectively. The SIMPLE-Severe study evaluated the efficacy and safety of 5-day and 10-day dosing durations of remdesivir in >300 adults hospitalized with severe COVID-19.

“Overall, the odds of a subject’s COVID-19 symptoms improving were similar for those in the five-day Veklury group as those in the 10-day Veklury group, and there were no statistically significant differences in recovery rates or mortality rates between the two groups,” noted the FDA press release.

The SIMPLE-Moderate study compared treatment with remdesivir for 5 days and remdesivir treatment for 10 days with standard of care. Overall, the odds of a participant’s COVID-19 symptoms improving were statistically significantly higher in the 5-day treatment group vs those receiving standard of care only.

The odds of improvement with the 10-day treatment group were numerically favorable, but not statistically significantly different vs the standard of care only group.

“The availability of a rigorously tested treatment that can significantly speed recovery and offers other benefits such as lower rates of progression to mechanical ventilation, provides hospitalized patients and their families important hope and offers healthcare providers a critical tool as they care for patients in need,” said Barry Zingman, MD, professor, Department of Medicine, Albert Einstein College of Medicine and Montefiore Medical Center, New York, in a Gilead press release.