U.S. innovators have developed an antiviral drug that can be used to treat patients hospitalized with COVID-19, part of America’s wide-ranging response to the global pandemic.
The U.S. Food and Drug Administration on October 22 approved Gilead Sciences’ antiviral remdesivir for adults and children older than 12 who are under hospital care for COVID-19. Remdesivir is the first antiviral the FDA has approved to combat the disease.
“Today’s 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,” Dr. Stephen M. Hahn, FDA commissioner, said in a statement.
The FDA will continue to approve new COVID-19 treatments as soon as they are found safe and effective, as required under the U.S. Federal Food, Drug, and Cosmetic Act. The FDA may also issue an Emergency Use Authorization before providing full approval to drugs for which clinical trials demonstrate a minimum duration of safety and compelling evidence of efficacy.
Prior to any approval, the FDA weighs the risks and benefits of a product using rigorous scientific standards. In approving remdesivir, the FDA analyzed data from three randomized, controlled clinical trials that included patients hospitalized with mild to severe cases of COVID-19.
Pharmaceutical company Gilead Sciences, based in Foster City, California, says remdesivir will help patients recover faster, thereby preserving scarce health care resources.
Through Operation Warp Speed, the United States is also supporting the development of numerous potential vaccines for COVID-19, including several that are in the final stages of testing. The operation has convened government scientists, pharmaceutical companies and others with the goal of developing a safe and effective coronavirus vaccine before the end of the year.
The United States also has invested in preparing manufacturers to bring COVID-19 vaccines to market quickly once they’re proven safe and effective.
“We’re getting ready so that when we get the good word — that we have the vaccine, we have the formula, we have what we need — we’re ready to go, as opposed to taking years to gear up,” President Trump said May 15.