FDA revokes emergency use authorization for chloroquine/hydroxychloroquine treatment of COVID-19

On June 15, the FDA announced the revocation of the Emergency Use Authorization (EUA) for the treatment of chloroquine/hydroxychloroquine for COVID-19Like the U.SBureau of Advanced Biomedical Research and Development (BARDA) earlier applied for an EUA for chloroquine/hydroxychloroquine, BARDA is now applying to revoke the EUA as part of a U.Sinteragency partnership to respond quickly to this changing public health emergencyToday's revocation request is based on new information, including clinical trial data, that led BARDA to conclude that the drug may be ineffective in the treatment of COVID-19 and that the potential benefits of the drug for such use do not exceed its known and potential risksspecific:is unlikely to have an antiviral effect, as recommended in the EUA applicationearly observations of a decrease in viral shedding after treatment of chloroquine or hydroxychloroquine were not consistently repeated, and recent data from randomized controlled trials showed that there was no significant difference between hydroxychloroquine and standard therapy in patients with COVID-19current U.Streatment guidelines do not recommend treating COVID-19 inpatients outside of clinical trialsthe latest data from a large randomized controlled trial showed that there was no evidence in hospitalized COVID-19 patients that chloroquine/hydroxychloroquine provided benefits for patient mortality or other clinical outcomes, the FDA believes that, based on this information and other evidence, it is no longer possible to consider chloroquine/hydroxychloroquine to be effective for the treatment of COVID-19, nor can it reasonably consider that the potential benefits of these products outweigh their known and potential risksAs a result, the FDA withdrew the emergency use of chloroquine and hydroxychloroquine for THE EUA of COVID-19.