FDA declines to authorize fluvoxamine as a COVID-19 treatment

The Food and Drug Administration said Monday that it won’t authorize fluvoxamine, a generic treatment for obsessive-compulsive disorder, as a COVID-19 therapy. “The FDA has determined that the data are insufficient to conclude that fluvoxamine may be effective in the treatment of nonhospitalized patients with COVID-19 to prevent progression to severe disease and/or hospitalization,” the regulator said, citing the need to look at the totality of scientific data. A group of physicians led by the University of Minnesota’s Dr. David Boulware in late 2021 formally requested that the FDA authorize fluvoxamine as a COVID-19 treatment. “I’m disappointed that FDA holds generics to different standards as big pharma, in this case using different definition of endpoints of what is a [COVID-19-related] ‘hospitalization,'” Boulware tweeted Monday.