The Food and Drug Administration announced Friday that it has provided Emergency Use Approval (EUA) for remdesivir in treating coronavirus patients who require hospitalization. With this approval, the drug is only available if administered intravenously, once a day for up to 10 days. No oral use of remdesivir has been tested or approved.
EUA is not a full approval of a drug by the FDA, but allows remdesivir to be used while full clinical trials are being conducted and completed. This approval is based on data from an NIH study that showed shortened hospitalizations by about 30% and reduced deaths by a third, although that reduction was not statistically significant. Importantly, toxicity from the remdesivir was minimal as compared to other drugs being tested for COVID-19, including chloroquine.
FDA has created a special emergency program for possible COVID-19 therapies, the Coronavirus Treatment Acceleration Program (CTAP). It specifically tries to advance new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. This was the first drug approved by this program.
The randomized, controlled study supporting remdesivir’s use was released on Wednesday. The study began in late February, and 1,063 patients with COVID-19 in 22 countries were given either the drug or a placebo. “The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,” commented Dr. Anthony Fauci on Wednesday.
I was a bit disappointed that the response to this study was mixed. It seemed some were trying to make talking points by being contrary. Several pundits complained that prior studies of the drug had not shown benefit; however those studies were much smaller and started the drug later in the course of the illness. The drug had a significant benefit even in very sick patients with mid-later stage disease.
Most antiviral drugs must be given immediately after the infection starts to be effective. Even though the response to remdesivir in this trial was limited, this approval should allow earlier interventions in patients and could result in greater treatment effects.
Maybe the most remarkable thing about these findings is simply the proof that antiviral drugs can treat this disease. This facilitates the development of drugs that are specifically designed for COVID-19 and could result in even better outcomes!
Gilead Sciences, the manufacturer of remdesivir, plans to donate 1.1 million vials of the drug and will work with the federal government to distribute it.