Cornelius (Neil) J. Clancy, MD

The FDA’s decision to approve remdesivir for the treatment of COVID‐19 in hospitalized adults and children aged 12 years of age and older caught many in health care off guard. The approval came hard on the heels of the release of nonpeer-reviewed data from the WHO Solidarity Trial that failed to show a mortality benefit from remdesivir treatment. In the earlier, double‐blind, placebo control ACTT trial published in the New England Journal of Medicine, remdesivir shortened time to recovery in SARS‐CoV‐2‐infected adults requiring oxygen (but not high‐flow oxygen or mechanical ventilation).

In a Q&A, the FDA justified its decision by noting the labeled indication considered time to improvement, which was not addressed by Solidarity. Remdesivir’s approval may very well be appropriate for the treatment of some hospitalized patients based on data from ACTT, a state‐of‐the-art randomized trial. However, it is not clear why approval was needed at this moment, in absence of an FDA advisory committee meeting and as Solidarity data are undergoing review. The drug was already available under an emergency use authorization, obviating need for immediate action.

Clinicians and hospitals will have to weigh the peer‐reviewed data from ACTT and Solidarity, when available, to determine where remdesivir will fit within their practices. At present, however, there is no evidence that it reduces mortality or provides benefit to the most critically ill patients. Controversy about the drug’s approval are heightened by its cost and mistrust of many in the FDA’s independence and transparency in our politically charged times.

Peter Chin-Hong, MD

The FDA approval of remdesivir likely sets into motion variation, heterogeneity and pragmatism surrounding the drug’s use.

For example, though hospitals are the intended site of remdesivir delivery, the FDA also acknowledged that any location that could provide equivalent services can also dispense it, so some patients may choose home delivery or seek care in specialized outpatient facilities.

In addition, though the studies leading to its approval were well-designed, it is important to note that the studies had different outcomes. While the NIH and Gilead-sponsored trials looked precisely at time to recovery which favored remdesivir use, the WHO open-labeled Solidarity trial looked at total hospitalization time and found no benefit to using remdesivir. This difference in outcomes may cause confusion, especially considering that health system rules regarding drugs that they put on their formularies can vary from one place to the next.

It is notable that the FDA does not require documentation for dispensing remdesivir. The expanded use authorization from earlier this year required would-be remdesivir users to provide proof of COVID-19 positivity and do daily liver and kidney function tests. But with the approval, there is no need for daily labs. This may lead to easier and more variation in use, including in patients with early, atypical or chronic symptoms.

Bottom line, this approval means there may not be much difference in remdesivir use in many frontline places, like my institution at the University of California, San Francisco. But it is possible that new populations for which there is less evidence for treatment may now be prescribed the drug.