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FDA Issues Emergency Use Authorization For Anti-malaria Drugs For Coronavirus

fda march30 lt

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to allow anti-malaria drugs hydroxychloroquine sulfate and chloroquine phosphate donated to the Strategic National Stockpile (SNS) as possible treatments for coronavirus (COVID-19) patients. This is the first EUA for a drug related to the COVID-19 response.

The U.S. Department of Health and Human Services (HHS) has already accepted 30 million doses of hydroxychloroquine sulfate donated by Sandoz, the Novartis generics and biosimilars division, and one million doses of chloroquine phosphate donated by Bayer Pharmaceuticals, for use in treating patients hospitalized with COVID-19 or for use in clinical trials.

Other companies such as Teva and Amneal as well as Mylan have ramped up production to provide additional supplies of the medication to the commercial market to ensure these drugs also remain available for patients dependent on them for treatment of malaria, lupus and rheumatoid arthritis.

Federal agencies, such as the National Institutes of Health and Biomedical Advanced Research and Development Authority (BARDA) of HHS' Office of the Assistant Secretary for Preparedness and Response (ASPR), are all working together to plan clinical trials.

The FDA issued the EUA to BARDA to allow the donated products to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible.

The donated drugs are approved by the FDA to treat malaria and other diseases, but not for the treatment of the coronavirus. Reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients. Clinical trials are needed to provide scientific evidence that these treatments are effective.

Scientists in U.S. and around the world have identified multiple potential therapeutics for COVID-19, including chloroquine and hydroxychloroquine.

In addition to accepting and distributing the donated medicines, HHS is funding clinical trials of two drugs, Kevzara (sarilumab) and remdesivir, and is supporting the earlier development of multiple potential therapeutic treatments, vaccines, and diagnostic tests for COVID-19.

A study in France seemed to suggest that hydroxychloroquine, combined with azithromycin, could work as a treatment for COVID-19.

The FDA has also issued a EUA for multiple diagnostics, for several other medical devices such as respiratory devices and a system for decontaminating them to allow for their reuse, and ventilators and ventilator equipment for the COVID-19 response.

Coronavirus that struck first in Wuhan, the capital of Hubei province in China, is fast spreading across the globe. As of this writing, the number of COVID-19 cases worldwide has exceeded 732,000, with more than 34,600 deaths reported.

Meanwhile, the U.S. has over 143,000 confirmed cases of COVID-19 infection, surpassing that of China, and the death increased to 2,500, according to Johns Hopkins University. New York is the worst-hit state in the U.S.

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