The US Food and Drug Administration (FDA) decided not to authorize the antidepressant fluvoxamine to treat Covid-19, saying the data did not show the drug to be an effective therapy to fight the virus.
“Based on review of the available scientific evidence, the FDA has determined that the data are insufficient to conclude that fluvoxamine may be effective in treating outpatients with Covid-19 to prevent progression to serious illness and/or hospitalization,” he said. the federal agency in a document published this Monday (16).
Professor David Boulware of the University of Minnesota has submitted the application for an emergency use authorization to the FDA that would allow doctors to prescribe fluvoxamine maleate to treat Covid-19 in outpatients.
The generic drug belongs to an old and widely used class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs.
Boulware said his request is less urgent as drugs like Pfizer’s Paxlovid are available, but he still believes the data supports the drug’s use in some Covid patients.
“There are effective therapies available. But not everyone has access to them. Not everyone can tolerate them. Some people have contraindications,” Boulware said in an interview. “And other places in the world, low- and middle-income countries, will not have access to any therapy.”
Boulware’s request was based on data from three trials, notably a study of 1,497 out-of-hospital Covid patients in Brazil.
Although the Brazilian study met its primary endpoint, showing an approximately 30% drop in hospitalizations in the fluvoxamine group, the FDA said there were uncertainties about the assessment, which measured a reduction in emergency room visits lasting longer than six hours. .
Boulware said the FDA used a different measure to count hospitalizations in other drug trials, including only critical care that lasted at least 24 hours.
“The standard they used for fluvoxamine was different from the other big pharmaceutical trials, with Paxlovid and molnupiravir (from Merck) and the monoclonals,” he said of other authorized Covid therapies.
“I was really very disappointed that they did,” he said.
Chad-98Weaver, a distinguished author at NewsBulletin247, excels in the craft of article writing. With a keen eye for detail and a penchant for storytelling, Chad delivers informative and engaging content that resonates with readers across various subjects. His contributions are a testament to his dedication and expertise in the field of journalism.
