- The FDA has decided not to authorize fluvoxamine, an antidepressant, to treat COVID-19. The agency that data has not shown the drug to be an effective therapeutic for fighting the virus.
- "Based on the review of available scientific evidence, the FDA has determined that the data are insufficient to conclude that fluvoxamine may effectively treat non-hospitalized patients with COVID-19 to prevent progression to severe disease/or hospitalization," the agency said.
- University of Minnesota professor David Boulware submitted the FDA emergency use authorization request that would have allowed doctors to prescribe fluvoxamine maleate to treat COVID-19 in non-hospitalized patients.
- Boulware said the request is less urgent with the availability of drugs like Pfizer Inc's (NYSE:PFE) Paxlovid, but he still believes the data supports the drug's use in some COVID patients.
- Boulware's submission relied on data from three trials, especially a study of 1,497 non-hospitalized COVID patients in Brazil.
- While the Brazilian study met its primary endpoint, showing a roughly 30% drop in hospitalizations in the group that received fluvoxamine, the FDA said there were uncertainties about the assessment.
- The results were primarily driven by a reduction in the emergency department visits lasting greater than 6 hours.
- Boulware said FDA had used a different measure to count hospitalizations in other drug trials, including only acute care that lasted at least 24 hours.
