The U.S. Food and Drug Administration (FDA) has approved the use of two anti-malaria drugs to treat patients infected by the new coronavirus.
On Sunday, the U.S. Department of Health and Human Services (HHS) said in a statement that chloroquine and hydroxychloroquine could be prescribed to teens and adults with COVID-19 "as appropriate, when a clinical trial is not available or feasible," after the FDA issued an Emergency Use Authorization (EUA). That marked the first EUA for a drug related to COVID-19 in the U.S., according to the statement.
Both chloroquine and hydroxychloroquine are used to treat diseases including malaria, and have "shown activity in laboratory studies against coronaviruses, including SARS-CoV-2 (the virus that causes COVID-19)," the HHS stated.
"Anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients. Clinical trials are needed to provide scientific evidence that these treatments are effective."
Under the EUA, health care providers and patients must be given fact sheets outlining the known risks and drug interactions of the medications.
The HSS said it accepted 30 million doses of hydroxychloroquine sulfate from an arm of the pharmaceutical company Novartis, and one million of chloroquine phosphate from Bayer Pharmaceuticals to be used for treating hospitalized COVID-19 patients or in clinical trials.
"These and other companies may donate additional doses, and companies have ramped up production to provide additional supplies of the medication to the commercial market," the HHS said.
"Given the importance of understanding the efficacy of these medications for the treatment and prevention of COVID-19, federal agencies, such as the National Institutes of Health and ASPR's Biomedical Advanced Research and Development Authority (BARDA), are working together to plan clinical trials."
The HHS said it hoped the donated drugs would "ease supply pressures" for the medications, and that it was working with manufacturers to boost production to ensure those who depend on them to treat conditions such as malaria, lupus, and rheumatoid arthritis have access.
The decision comes after FDA commissioner Stephen Hahn said that the agency would "take a closer look" at chloroquine in "a large pragmatic clinical trial—to actually gather that information and answer that question that needs to be asked and answered," after President Donald Trump said chloroquine and hydroxychloroquine showed promise in COVID-19 patients.
By Kashmira Gander | Newsweek 2020-03-30
