Government/Health

FDA gives emergency approval for Trump-touted anti-malaria drugs to treat coronavirus patients

(USA Features) The Food and Drug Administration has given emergency approval to utilize long-standing anti-malaria drugs in the treatment of coronavirus victims.

The drugs, chloroquine phosphate and hydroxychloroquine sulfate, have been touted by President Donald Trump and used in an off-label capacity to treat some coronavirus patients with encouraging results.

However, they had not been approved by the FDA to treat COVID-19, the disease caused by the novel coronavirus.

The Department of Health and Human Services said in a statement that it has received 30 million doses of hydroxychloroquine sulfate donated by Sandoz and 1 million doses of chloroquine phosphate donated by Bayer Pharmaceuticals for the national stockpile of drugs and medical supplies.

The drugs, which have been long approved for treating malaria, lupus and other diseases, may now be used “in treating patients hospitalized with COVID-19 or for use in clinical trials,” the HHS statement said.




There are currently no FDA-approved treatments for the novel coronavirus, but “both drugs have shown activity in laboratory studies against coronaviruses, including SARS-CoV-2 (the virus that causes COVID-19).”

“Anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients,” said the statement. “Clinical trials are needed to provide scientific evidence that these treatments are effective.”

Meanwhile, Health and Human Services Secretary Alex Azar credited the president’s “bold leadership” and the “hard work of FDA and HHS’s Assistant Secretary for Preparedness and Response” for the large donations.

“We’ll continue working around the clock to get American patients access to therapeutics that may help them battle COVID-19, while building the evidence to evaluate which options are effective,” said Azar.

Democratic governors in Michigan and Nevada have issued executive orders restricting prescriptions of the two drugs amid reports of hoarding.


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