The U.S. Department of Health and Human Services (HHS) has received more than 30 million doses of antimalarial drugs believed capable of treating coronavirus and the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) Saturday to release those drugs to coronavirus patients.
HHS announced Sunday it had accepted 30 million doses of hydroxychloroquine sulfate from Sandoz and one million doses of chloroquine phosphate from Bayer Pharmaceuticals intended for use in treating coronavirus patients after the FDA’s authorization. The authorization only approves the treatment under emergency circumstances, and not for normal, typical use. The drugs are not proven to be a cure or a vaccine for coronavirus.
The drug doses were being stored in the Strategic National Stockpile for medicines but will be distributed to hospitals to treat certain coronavirus patients.
President Donald Trump had previously touted various forms of antimalarial drugs, including chloroquine and hydroxychloroquine as promising treatments for coronavirus patients. In a March 19 press conference, Trump said the FDA was working quickly to review those treatments for approval in treating coronavirus patients, and that some patients were already being given the experimental treatments under “compassionate use” guidelines.
The FDA’s latest decision releases 30 million doses of those treatments for wider use even without a full clinical trial. The FDA responded to a letter from a doctor, requesting the release of the donated drug stockpile and agreed to that release under certain guidelines. Those guidelines include the provision that the emergency authorization only lasts as long as HHS holds its emergency declaration on coronavirus in effect.
The HHS announcement still indicated, “Clinical trials are needed to provide scientific evidence that these treatments are effective.”
The drugs have been given prior approval as antimalarial treatments, but are not yet approved as treatments for the novel coronavirus, COVID-19. HHS said the EUA is separate from the FDA’s review of the treatments under investigational drug applications.
HHS added the caveat that the emergency use of the drugs is only prescribed when its use as a potential treatment for coronavirus is deemed to outweigh the potential risks the unproven product may pose and there are not other more appropriate treatment options available.
“Use of the donated medications is expected to help ease supply pressures for the drug, and the FDA is also working with manufacturers of chloroquine and hydroxychloroquine to increase production to ensure these drugs also remain available for patients dependent on them for treatment of malaria, lupus and rheumatoid arthritis,” the HHS statement noted. “Some states and retail pharmacies also have taken action to preserve the supply of these and other drugs for these patients.”
The emergency authorization comes as the Trump administration has projected the U.S. could see between 100,000 and 200,000 coronavirus related deaths and has asked the nation to maintain mitigation practices through the month of April.