On Thursday, the Food and Drug Administration approved the antiviral drug remdesivir for patients with COVID-19 severe enough to require hospitalization. Remdesivir has been on the Emergency Use Authorization (EUA) list for COVID-19 patients since May 1, 2020.
This approval does not include the entire population that had been authorized to use remdesivir under the EUA. The antiviral drug has been approved for use in adult and pediatric patients 12 years of age and older who weigh at least 88 pounds. To ensure continued access for pediatric patients who do not meet the age or weight requirement, the FDA revised the EUA to authorize the drug’s use for pediatric patients weighing 7.7 to 88 pounds. Clinical trials assessing the safety and efficacy of remdesivir in the pediatric patient population are still ongoing.
The FDA pointed to three randomized, controlled clinical trials that show remdesivir’s benefits outweigh its risks for hospitalized COVID-19 patients. The first study conducted in February out of the National Institute of Allergy and Infectious Diseases (NIAID) demonstrated that patients who received remdesivir had a 31% faster time to recovery than those who received a placebo. Results also suggested a survival benefit, with a mortality rate of 8% for the group receiving remdesivir versus 12% for the placebo group.
A second study, begun in March, compared symptomatic results of hospitalized patients with moderate COVID-19 who were treated with remdesivir for 5 days and 10 days versus standard of care. On day 11, those treated with a 5-day course had a significantly higher chance of improved symptoms compared with patients who received only standard of care. However, those in the 10-day treatment group did not see improvement that was statistically significant.
The third study examined hospitalized adults with sever COVID-19 who received a 5-day course of remdesivir versus a 10-day course of remdesivir. On day 14, there was no statistically significant differences in recovery rate or mortality rates between the two groups.
A remdesivir study published in August in JAMA—and not referenced in the FDA approval—concluded the drug may not have a significant effect on COVID-19 patients with a moderate form of the virus. The results indicate remdesivir had more of an impact on patients who received a 5-day course than a 10-day course. However, even for those in the 5-day course group, the statistically significant difference in clinical status compared with standard care was deemed to be “of uncertain clinical importance.”
In July, Gilead—the pharmaceutical company behind remdesivir—announced it will charge $2,340 for a typical 5-day treatment course for people covered by government health programs in the United States and other developed countries. American private insurers will pay $3,120 for a 5-day course, while Gilead will allow generic versions of the drug in developing worlds to ensure a lower price.
At this time, remdesivir is the only approved treatment for COVID-19.
“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” said FDA Commissioner Stephen Hahn, M.D. “[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. 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.”