June 15, 2020

The U.S. FDA has revoked its Emergency Use Authorization (EUA) for oral formulations of chloroquine and hydroxychloroquine to be used as potential treatments for COVID-19.

On March 28, 2020, the FDA granted an EUA for both drugs based on early clinical data that suggested they may be of use in treating COVD-19. It is now revoking that authorization based on new information, including clinical trial data, that has led the Biomedical Advanced Research and Development Authority (BARDA), an office of the U.S. Department of Health and Human Services (HHS), to conclude the following:

  • Chloroquine and hydroxychloroquine may not be effective treatments for COVID-19.
  • The drugs’ potential benefits for such use do not outweigh their known and potential risks.

An EUA can only be issued for a drug therapy if it is reasonable to believe, based on current scientific evidence, that the product may be effective in diagnosing, treating, or preventing the disease in question, and the known and potential benefits outweigh the known and potential risks. If these conditions are no longer met, as is the case with chloroquine and hydroxychloroquine for the treatment of COVID-19, the EUA is no longer valid. Further details regarding the FDA’s decision can be found on the agency’s website.

In addition, the FDA has issued a warning that concomitant use of chloroquine or hydroxychloroquine with the investigational antiviral drug remdesivir may reduce remdesivir’s effectiveness. The findings come from a non-clinical laboratory study. Further information regarding the warning is available on the FDA’s website.

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