FDA gives emergency approval for antimalarial drugs in treating coronavirus patients

By Washington Times

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(WASHINGTON TIMES) – The U.S. Food and Drug Administration issued late Sunday an emergency-use authorization for two antimalarial drugs for use in treating patients infected with the novel coronavirus.

The drugs, chloroquine phosphate and hydroxychloroquine sulfate, have been touted by President Trump and used off-label anecdotally with encouraging results, but they had not been FDA-approved for treating COVID-19, the disease caused by the novel coronavirus.

In a statement, the Department of Health and Human Services also said that it had also 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 pharmaceuticals and medical supplies.

The drugs, which have been long approved for treating malaria, lupus and other diseases, may 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.”

Health and Human Services Secretary Alex Azar credited Mr. Trump’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,” Mr. Azar said.

Democratic governors in at least two states, Michigan and Nevada, have restricted prescriptions of the two drugs amid reports of hoarding, spurring allegations on the right that Democrats are attempting to discredit medications promoted by Mr. Trump.

Dr. Luciana Borio, who served as FDA acting chief scientist under then-President Barack Obama, raised questions about the emergency-use order, saying she wanted to know which FDA official signed off on the order “despite the total lack of scientific evidence” about the drugs’ benefit in treating COVID-19.

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