FDA approves limited use of malaria drugs for coronavirus - New York Post

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The Food and Drug Administration has issued a limited emergency-use authorization for two antimalarial drugs that President Trump has touted for the treatment of coronavirus patients.

In a statement published Sunday, the US Department of Health and Human Services cited recent donations of medications to the Strategic National Stockpile, including chloroquine and hydroxychloroquine, Politico reported.

It said the FDA had allowed the drugs “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 HSS said that Sandoz, a division of the Novartis Group, had donated 30 million doses of hydroxychloroquine, while Bayer donated 1 million doses of chloroquine.

The FDA has already given New York state permission to give desperately ill patients a cocktail of hydroxychloroquine and azithromycin on a “compassionate care” basis.

“Let’s see how it works,” Trump said during a press conference Sunday, regarding the Empire State’s efforts. “It may, it may not.”

HHS Secretary Alex Azar praised Trump and the emergency-use authorization.

“Scientists in America and around the world have identified multiple potential therapeutics for COVID19, including chloroquine and hydroxychloroquine,” Azar tweeted Sunday night.

Trump helped create a recent flurry of demand for the drugs when he announced that chloroquine “could be a game-changer.” He also said hydroxychloroquine could be used in prevention.

Dr. Anthony Fauci, the country’s leading infectious-disease expert, has said there is no substantive proof, at least yet, that either drug works in the battle against the deadly pandemic, only anecdotal information.

Two US medical bodies — the National Institutes of Health and the Biomedical Advanced Research and Development Authority — are working to plan clinical trials involving the drugs, according to Agence France-Presse.



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