FDA approves emergency use of antimalarial drugs to treat coronavirus

by WorldTribune Staff, March 30, 2020

Antimalarial drugs chloroquine phosphate and hydroxychloroquine sulfate have been approved by the U.S. Food and Drug Administration (FDA) for use in treating coronavirus patients.

The drugs have been hailed by President Donald Trump as potential coronavirus “game changers” which led to criticism from his vocal detractors.

The Department of Health and Human Services (HHS) said in a statement that the FDA’s authorization would allow 30 million doses of hydroxychloroquine sulfate and 1 million doses of chloroquine phosphate to be donated to the Strategic National Stockpile. The doses of hydroxychloroquine sulfate were donated by Sandoz, while the chloroquine phosphate was developed by Bayer Pharmaceuticals.

The products will 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,” HHS said.

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

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

“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,” Azar said.

The Washington Times’ Valerie Richardson noted that Democratic governors in 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 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.

Intelligence Brief __________ Replace The Media