UPDATED: FDA says it has not approved Chloroquine for Covid-19 use, contradicting Trump’s statement

UPDATED: The FDA says it has not approved Chloroquine for Covid-19 use, contradicting the President Trump’s statement.

U.S. Food and Drug Administration Commissioner Stephen Hahn addressed the ongoing work of the agency in terms of its work on potential treatments and vaccines for the COVID-19 coronavirus currently spreading globally.

Despite a claim early in Thursday’s White House briefing on the pandemic by President Donald Trump that one proposed treatment, anti-malarial chloroquine, had already been approved by the FDA for COVID-19 treatment, Hahn said that in fact the agency is currently looking at widespread clinical trials of the drug, but it is not yet approved for that use.

“In the short term, we’re looking at drugs that are already approved for other indications,” Dr. Hahn said. “Many Americans have read studies and heard media reports about this drug chloroquine, which is an anti-malarial drug. It’s already approved, as the president said, for the treatment of malaria [Trump had not said this, but had instead said it was now approved for COVID-19] as well as an arthritis condition. That’s a drug that the president has directed us to take a closer look at, as to whether an expanded use approach to that could be done to actually see if that benefits patients. And again, we want to do that in the setting of a clinical trial, a large pragmatic clinical trial to actually gather that information and answer the question that needs to be answered.”

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The United States of America have approved the use of Anti-Malaria Drug, Chloroquine as treatment against CoronaVirus, President Trump said on Thursday.

The president told reporters;

“We’re going to be able to make that drug available almost immediately, and that’s where the FDA (Food and Drug Administration) has been so great,”



“They’ve gone through the approval process — it’s been approved. They took it down from many, many months to immediate. So we’re going to be able to make that drug available by prescription.”

However, the FDA Commissioner Stephen Hahn later indicated that, while the drug has not yet been formally approved, access to it was being expanded so that authorities could gather more data.

This is known as “compassionate use.”

“If there is an experimental drug that is potentially available, a doctor could ask for that drug to be used in a patient. We have criteria for that and very speedy approval for that,” said Hahn.

AFP

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