BioCentury
ARTICLE | Regulation

FDA wants more data for common antidepressant to treat COVID-19 

Fluvoxamine trial hits endpoint but FDA not persuaded  

May 17, 2022 11:28 PM UTC

FDA’s rejection of an application to repurpose fluvoxamine to treat COVID-19 is a sign that the availability of effective antivirals, and criticism for exposing patients to ineffective treatments such as hydroxychloroquine, have caused the agency to raise the bar on EUAs.

The lack of a well-defined mechanism of action, along with clinical data that FDA did not consider persuasive, caused the agency to rebuff the fluvoxamine EUA. The two repurposed drugs that have retained their EUAs, dexamethasone and Veklury remdesivir from Gilead Sciences Inc. (NASDAQ:GILD), were authorized based on increased survival among hospitalized patients in large, randomized trials...