FDA approves remdesivir for potential, emergency treatment of COVID-19

Following the results of two clinical trials for the experimental antiviral drug remdesivir, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) last week, opening it to use as a treatment for those with severe cases of COVID-19.

“Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use,” the FDA said in a statement.

Originally intended for use against MERS and SARS coronaviruses, remdesivir has found new life as a potential means of combating COVID-19. The disease has become a global pandemic since its discovery in December 2019. Remdesivir is a product of Gilead Sciences Inc., and, though there is currently little data about its safety and effectiveness, preliminary studies showed it shortened the time to recovery among some patients. In a National Institutes of Health-sponsored test, it notably reduced hospital stays among patients, though it provided no great reduction in mortality.

Now, remdesivir will be able to be used by health care providers where appropriate to treat those adults and children hospitalized with severe suspected or lab-confirmed cases of COVID-19. If patients have low blood oxygen levels or need oxygen therapy or more intensive breathing support, they are eligible for the drug.

“Today’s action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” FDA Commissioner Stephen M. Hahn said. “There’s tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19, and through our Coronavirus Treatment Acceleration Program, the FDA is working around-the-clock and using every tool at our disposal to speed these efforts.”

Fact sheets with information on remdesivir dosing, side effects, and drug interaction details are now being made available to health care providers and patients alike. Notably, those side effects include increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver, along with low blood pressure, nausea, vomiting, sweating, and shivering.