“Based on a review of the available scientific evidence, the FDA has determined that the data are insufficient to conclude that fluvoxamine may be effective in the treatment of outpatient Covid-19 patients by preventing disease progression severe or at risk of hospitalization” – news agency Reuters cited the FDA notice issued on May 16.
FDA logo is placed in front of headquarters in White Oak, Maryland – USA – Photo: REUTERS
Previously, professor – Dr. David Boulware from the University of Minnesota – USA submitted an emergency use authorization request to the FDA, to allow doctors to prescribe fluvoxamine, the full name is fluvoxamine maleate, to treat Covid-19 in non-hospitalized patients. In this regimen, fluvoxamine is not used to treat depression but will have a similar effect to an antiviral drug.
However, Dr. Boulware also admits his request is less urgent given the availability of drugs like Paxlovid (Pfizer’s new antiviral drug, backed by both the FDA and the World Health Organization (WHO) ),
But he still believes that this will bring more means and options in the treatment of Covid-19, especially in low- and middle-income countries, where they have difficulty accessing supportive drugs. other Covid-19 treatment. Fluvoxamine is a long-standing popular antidepressant on the world market and is cheap.
Dr. Boulware’s report is based on data from three trials, specifically a study of 1,497 non-hospitalized Covid-19 patients in Brazil.
While the Brazilian study met the primary endpoint, showing a reduction in hospital admissions of about 30% in the group given fluvoxamine, the FDA said there were uncertainties regarding its assessment, which measures the extent of reductions in these factors. emergency department visits lasting more than 6 hours.
However, Dr. Boulware said he was disappointed that the FDA did not evaluate fluvoxamine according to the same set of standards as other trials on Paxlovid, Molnupiravir or monoclonal variants.
Previously, the FDA approved a number of other antiviral drugs to support the treatment of Covid-19 patients at home, the first being Molnupiravir, which has become quite popular around the world; Recently Paxlovid.