FDA revokes EUA for chloroquine, hydroxychloroquine

By The Science Advisory Board staff writers

June 15, 2020 -- The U.S. Food and Drug Administration (FDA) on June 15 revoked the emergency use authorization (EUA) for chloroquine phosphate and hydroxychloroquine sulfate for patients with COVID-19.

According to the agency, the EUA was revoked because a clinical trial demonstrated that the drugs had no benefit on mortality or in speeding recovery. Furthermore, recent data suggested the drugs do not kill or inhibit SARS-CoV-2, therefore the legal criteria for issuing the EUA are no longer met. Based on its ongoing analysis, the FDA determined that the drugs are unlikely to be effective in treating COVID-19 for authorized uses in the EUA. Furthermore, in consideration of ongoing serious cardiac side effects from the drugs, the benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for authorized use.

The EUA was originally issued on March 28 at the request of the U.S. Biomedical Advanced Research and Development Authority (BARDA). Today, June 15, in consultation with the FDA, BARDA sent a letter to the FDA requesting revocation of the EUA based on new science and data.

The FDA has a responsibility to regularly review the appropriateness of EUAs, and the agency will continue to review emerging information associated with emergency uses for the authorized products, including chloroquine and hydroxychloroquine.

Researchers call for rapid drug repurposing to fight COVID-19
Filling the therapeutic gap for coronavirus treatments with existing drugs approved for other uses could greatly benefit patients around the world. Researchers...
Certara, DMTC study preventative use of chloroquine for COVID-19
Certara and DMTC have entered into a research collaboration to evaluate the preventative use of chloroquine in healthcare workers at risk of infection...

Copyright © 2020 scienceboard.net


Register below for our weekly Letter from the Editor to receive the latest Science news and insights.
Email
Connect
Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter