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The agency revoked its emergency use authorization (EUA) for the drug, while warning about a dangerous interaction with remdesivir.
FDA revoked the emergency use authorization (EUA) for chloroquine phosphate and hydroxychloroquine sulfate in hospitalized COVID-19 patients, and warned about a potential drug interaction with the investigational antiviral drug remdesivir and hydroxychloroquine.
“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” FDA said in a press release.
The FDA is also concerned about the “ongoing serious cardiac adverse events and other potential serious side effects,” it said. “The known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”
The FDA granted the EUA on March 28 based on the science and data available at the time. “Today, in consultation with the FDA, Biomedical Advanced Research and Development Authority (BARDA) sent a letter to the FDA requesting revocation of the EUA based on up to date science and data,” the agency said.
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Since the EUA was granted, new data on heart risks associated with the medication have been revealed.
In addition, FDA said that recent results from a large randomized clinical trial in hospitalized patients, a population similar to the population for which chloroquine and hydroxychloroquine were authorized for emergency use, 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. The totality of scientific evidence currently available indicate a lack of benefit.”
Meanwhile, FDA also warned healthcare providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir, it said in a press release.
“The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir,” FDA said.
In addition, FDA revised the fact sheet for healthcare providers to clarify dosing and administration recommendations and to provide additional safety data and supporting data from clinical trials conducted by both the National Institutes of Health and the drug sponsor, Gilead Sciences.
The fact sheet for patients and caregivers was also updated to include additional information about possible allergic reactions and to alert patients to tell their healthcare providers if they are taking chloroquine phosphate or hydroxychloroquine sulfate.
While the safety and efficacy of remdesivir for the treatment of COVID-19 continue to be evaluated, preliminary clinical trial results have shown that, on average, patients treated with remdesivir had more rapid time to recovery, FDA said.