Remdesivir Approved as First COVID-19 Treatment

The U.S. Food and Drug Administration (FDA) has approved the antiviral drug remdesivir (brand name Veklury, Gilead Sciences) for treating patients hospitalized with COVID-19. This is the first treatment for COVID-19 to receive FDA approval.

This therapy is indicated for use in patients 12 years of age and older, and weighing at least 40 kilograms (about 88 pounds). The FDA notes remdesivir should only be administered in a hospital or other healthcare setting capable of providing acute care comparable to inpatient hospital care.

This approval does not include the entire population that had been authorized to use remdesivir under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA to authorize the drug’s use for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg, or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. Clinical trials assessing the safety and efficacy of remdesivir in this pediatric patient population are ongoing.

“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” says FDA Commissioner Stephen M. Hahn, MD. “The October 22 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. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”

The approval was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19.

One randomized, double-blind, placebo-controlled clinical trial (ACTT-1), conducted by the National Institute of Allergy and Infectious Diseases, evaluated how long it took for subjects to recover from COVID-19 within 29 days of being treated. The trial looked at 1,062 hospitalized subjects with mild, moderate and severe COVID-19 who received remdesivir (n=541) or placebo (n=521), plus standard of care. Recovery was defined as either being discharged from the hospital or being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care. The median time to recovery from COVID-19 was 10 days for the remdesivir group, compared to 15 days for the placebo group, a statistically significant difference. Overall, the odds of clinical improvement at Day 15 were also statistically significantly higher in the remdesivir group when compared to the placebo group.

A second randomized, open-label multicenter clinical trial of hospitalized adult subjects with moderate COVID-19 compared treatment with remdesivir for five days (n=191) and treatment for 10 days (n=193) with standard of care (n=200). Researchers evaluated the clinical status of subjects on Day 11. Overall, the odds of a subject’s COVID-19 symptoms improving were statistically significantly higher in the five-day remdesivir group at Day 11 when compared to those receiving only standard of care. The odds of improvement with the 10-day treatment group were numerically favorable, but not statistically significantly different.

A third separate, randomized, open-label multi-center clinical trial of hospitalized adult subjects with severe COVID-19 compared treatment with remdesivir for five days (n= 200) and treatment for 10 days (n= 197). Researchers evaluated the clinical status of subjects on Day 14. Overall, the odds of a subject’s COVID-19 symptoms improving were similar for those in the five-day remdesivir group as those in the 10-day group, and there were no statistically significant differences in recovery rates or mortality rates between the two groups.

The FDA granted this application Fast Track and Priority Review designations. The agency also granted this application a Material Threat Medical Countermeasure Priority Review Voucher, which provides additional incentives for certain medical products intended to treat or prevent harm from specific chemical, biological, radiological and nuclear threats. The FDA granted approval and reissued the revised EUA to Gilead Sciences Inc.