Remdesivir just got FDA approved. Does this change anything?

As of late October, Remdesivir (made by Gilead) became the first and only fully FDA approved treatment for COVID-19 in the US. Remdesivir is a medication that must be given through an IV and thus is only used on patients 12 years and older who require hospitalization. 

Since May, it has been in use for the treatment of COVID under an emergency use authorization and has helped to shorten the recovery time of some hospitalized patients, typically those requiring oxygen support. A randomized and controlled study of 1,060 hospitalized patients done by Gilead, “found that Remdesivir contributed to significantly-reduced mortality among those in the early stages of receiving oxygen support. However, it did not find a statistically significant reduction in death rates across the entirety of patients treated in the trial.” 

A study coordinated by the WHO including about 5,000 patients also showed that it did not have a significant effect on death rates and thus as of last week, they issued a conditional recommendation against its use. 

That said, the NIH and Infectious Diseases Society of America continue to recommend Remdesivir as part of their protocols as it does seem to prevent some people from getting sicker or requiring more oxygen support and generally has minimal side effects. 

As of a few days ago, the NIH is launching a study that will look at Remdesivir combined with other medications (either dexamethasone, a steroid, or baricitinib, an inflammatory modulator). Over time, we certainly will learn more about Remdesivir’s potential benefits in treatment of COVID-19 and hopefully more effective treatments will continue to be developed. So far, Gilead has been able to meet real-time demand in the US and said they planned to continue to increase the supply of the drug to be able to meet global demand. 

Jackie Phillips, MD, December 1, 2020