FDA expands use of remdesivir as COVID-19 treatment
The Food and Drug Administration (FDA) late Friday evening announced it was allowing the drug remdesivir to be used for all patients hospitalized with the coronavirus.
The agency said in a press release that it would expand the emergency use authorization of the drug to allow it to be used for “treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.”
“The FDA continues to make safe and potentially helpful treatments for COVID-19 available as quickly as possible in order to help patients,” said FDA Commissioner Stephen Hahn. “The data to support today’s action are encouraging. The data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus.
“We are working with drug developers to conduct randomized clinical trials to further study the safety and effectiveness of a number of potential therapies for COVID-19,” he added.
The FDA said in its release that it has determined that it is “reasonable to believe” that remdesivir may be effective for the treatment of suspected or confirmed coronavirus cases in all hospitalized adults and children.
Studies have suggested remdesivir is not a cure-all for the coronavirus, with data from the New England Journal of Medicine showing that it alone does not cure patients who are experiencing severe symptoms of COVID-19, though it did help patients recover faster than those who did not receive the drug.
The Trump administration has gone all in on the drug, purchasing early the entire global supply of the antiviral medicine.
“It seems to be a pattern of approval without science, without data, without evidence,” Eric Topol, vice president for research at Scripps Research in La Jolla, Calif., and a national expert on the use of data in medical research, told USA Today.
The FDA first allowed remdesivir to be used for hospitalized patients who required oxygen but weren’t sick enough to require ventilation.