FDA Approves Malaria Drug Touted By President Trump

A drug President Donald Trump backed as a possible “game changer” in the fight against the coronavirus pandemic received an emergency-use designation from U.S. regulators.

The Health and Human Services Department accepted 30 million doses of the drug, hydroxychloroquine, from Novartis AG’s Sandoz unit, Secretary Alex Azar said in a statement late Sunday.

Normally used to treat malaria, hydroxychloroquine yielded promising yet inconclusive results in a small coronavirus trial. While Trump has said the drug is safe, it does carry significant side effects. Some people have been sickened, with one reported death, after taking various versions to try to ward off the new illness.

Trump said 1,100 patients in New York City are getting treatment using hydroxychloroquine. As global cases surged past 700,000, the city has emerged as one of the pandemic’s hot spots.

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“Let’s see how it works,” Trump said in his daily briefing Sunday. “It may, it may not.”

The Food and Drug Administration gave emergency use authorization to hydroxychloroquine and a related malaria drug, chloroquine, according to the statement. The agency can authorize emergency use when there are no available alternatives and the “known and potential” benefits of the product outweigh known and potential risks.

Efforts to find solutions to the virus’s advance are mounting as the number of worldwide cases soars, and health systems in Italy and Spain threaten to crack under the burden of desperately ill and contagious patients. A variety of treatments, including Gilead Sciences Inc.’s remdesivir, are currently in randomized, controlled clinical trials.


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