FDA declined approval of antidepressant as COVID-19 treatment

The generic drug belongs to the SSRI class of antidepressants, which has been around for a long time.

The US Food and Drug Administration (FDA) has chosen not to approve the antidepressant fluvoxamine for the treatment of COVID-19, citing a lack of evidence that the drug is an effective treatment for the virus. "Based on the review of available scientific evidence, the FDA has determined that the data are insufficient to conclude that fluvoxamine may be effective in the treatment of non-hospitalized patients with COVID-19 to prevent progression to severe disease and/or hospitalization," the agency said in a document published on Monday. Dr. David Boulware of the University of Minnesota submitted an emergency use authorisation request to the FDA, which would have authorized doctors to give fluvoxamine maleate to non-hospitalized COVID-19 patients.

The generic drug is part of an antidepressant class known as selective serotonin reuptake inhibitors, or SSRIs. With the advent of medications like Pfizer's Paxlovid, Boulware's request is less urgent, but he still believes the research supports the drug's use in some COVID-19 patients. Boulware's application was based on findings from three trials, including a Brazilian study of 1,497 non-hospitalized COVID-19 patients. While the primary goal of the Brazilian research was met, with an approximately 30% reduction in hospitalizations in the fluvoxamine group, the FDA expressed concerns about the assessment, which measured reduction in emergency department visits lasting more than 6 hours. Boulware said the FDA had used a different measure to count hospitalizations in other drug trials.