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23-06-2020 | COVID-19 | News

Regulatory update

COVID-19: FDA revokes Emergency Use Authorization for hydroxychloroquine

Author: Claire Barnard


medwireNews: The US FDA no longer permits the use of chloroquine or hydroxychloroquine for the treatment of COVID-19 outside of clinical trial settings.

The Emergency Use Authorization (EUA), which permitted the use of these agents to treat certain hospitalized COVID-19 patients when participation in a clinical trial was not possible, was revoked because “the legal criteria for issuing an EUA are no longer met,” announced the FDA in a news release.

Following “rigorous” assessment of emerging data, the agency said that“[t]he totality of scientific evidence currently available indicate a lack of benefit.”

Considered alongside the risks including serious cardiac events, “the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks” when used for the treatment of COVID-19, concluded the FDA.

Both agents are approved for the treatment of malaria, while hydroxychloroquine is also approved for systemic lupus erythematosus and rheumatoid arthritis.

medwireNews is an independent medical news service provided by Springer Healthcare. © 2020 Springer Healthcare part of the Springer Nature Group

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