FDA revokes emergency use authorisation for chloroquine and hydroxychloroquine as COVID-19 treatments

The US Food and Drug Administration (FDA) has announced that it has revoked the emergency use authorisation (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalised patients with COVID-19. 

The FDA said it determined the legal criteria for issuing an EUA are no longer being met. Based on its ongoing analysis of the EUA and emerging scientific data, the agency found that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorised uses in the EUA.

Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorised use, the FDA has explained. 

“While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the EUA was no longer appropriate. This action was taken following a rigorous assessment by scientists in our Center for Drug Evaluation and Research,” said Dr Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research. 

Recent results from a large randomised clinical trial in hospitalised patients demonstrated that hydroxychloroquine showed no benefit on mortality or in speeding recovery. This outcome was consistent with other new data, including data showing that the suggested dosing regimens for chloroquine and hydroxychloroquine are unlikely to kill or inhibit the virus that causes COVID-19. According to the FDA, the totality of scientific evidence currently available indicate a lack of benefit.

The Biomedical Advanced Research and Development Authority (BARDA) within the US Department of Health and Human Services (HHS) originally requested the EUA covering chloroquine and hydroxychloroquine. In consultation with the FDA, BARDA has now sent a letter to the FDA requesting revocation of the EUA based on up to date science and data.

“We’ve made clear throughout the public health emergency that our actions will be guided by science and that our decisions may evolve as we learn more about the SARS-CoV-2 virus, review the latest data and consider the balance of risks versus benefits of treatments for COVID-19,” said FDA Deputy Commissioner for Medical and Scientific Affairs Dr Anand Shah. “The FDA always underpins its decision-making with the most trustworthy, high-quality, up-to-date evidence available. We will continue to examine all of the EUAs the FDA has issued and make changes, as appropriate, based on emerging evidence.”