FDA Revokes EUA for Hydroxychloroquine

June 15, 2020

Citing clinical trial data that hydroxychloroquine did not show benefits for COVID-19 patients, FDA removes emergency use authorization for the drug as a treatment for the novel coronavirus.

FDA has revoked the emergency use authorization (EUA) for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) as treatments for COVID-19, according to a June 15, 2020 announcement.

In a statement on its website, the agency noted that it “has determined that CQ and HCQ are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use.”

Chloroquine and hydroxychloroquine are approved to treat or prevent malaria, and hydroxychloroquine is approved to treat autoimmune conditions. The potential use of the drugs to treat COVID-19 was met with controversy in the medical community and suggestions of political pressures on scientific decision-making. An initital demand for the unproven drug created temporary shortages for patients prescribed the drug for approved treatments.

Trials results trigger EUA revocation

In a recent clinical trial of hospitalized COVID-19 patients, hydroxychloroquine did not demonstrate any benefit on mortality or in speeding recovery, FDA reported.  These findings were consistent with other data, including data that the drugs are unlikely to kill or inhibit the novel coronavirus, indicating a lack of benefit, the agency said in a press statement.

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

The US Department of Health and Human Services (HHS) declared a public health emergency due to the COVID-19 pandemic on Feb. 4, 2020. FDA issued an EUA for HCQ and CQ on March 28, 2020 at the request of the Biomedical Advanced Research and Development Authority (BARDA), part of HHS. FDA noted that its decision to issue the EUA was based on scientific information available at the time that potential benefits of CQ and HCQ in treating COVID-19 outweighed the known and potential risks of using the drugs. FDA reported that it was withdrawing the EUA following a request from BARDA.

Clinical trials using the drugs that currently are in progress will continue, FDA reported. Any of the drugs distributed from the Strategic National Stockpile under the EUA are still authorized for emergency use to hospitalized patients who have already been treated with the drugs, “to the extent found necessary by the patient’s attending physician.”

Source: FDA