The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to the US Department of Health and Human Services’s (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to 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.
“Scientists in America and around the world have identified multiple potential therapeutics for COVID-19, including chloroquine and hydroxychloroquine,” HHS Secretary Alex Azar said in a statement.
“The President’s bold leadership and the hard work of FDA and HHS’s Assistant Secretary for Preparedness and Response have succeeded in securing this large donation of medicine. 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.”
Hydroxychloroquine sulfate and chloroquine phosphate are oral prescription drugs approved to treat malaria and other diseases. Although there are no currently approved treatments for COVID-19, 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. Clinical trials are needed to provide scientific evidence that these treatments are effective.
An EUA may be issued if the FDA determines that, among other criteria, the known and potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or condition, outweigh the known and potential risks of the product, and there are no adequate, approved, available alternatives.
Sandoz and Bayer are the latest companies stepping up to strengthen the U.S. response to COVID-19, and ASPR is working with additional companies willing to donate doses of hydroxychloroquine and chloroquine. Companies interested in donating goods or services should contact email@example.com or visit https://www.fema.gov/coronavirus/how-to-help.
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. Some states and retail pharmacies also have taken action to preserve the supply of these and other drugs for these patients.
In addition to accepting and distributing the donated medicines, HHS is funding clinical trials of two drugs, Kevzara (sarilumab) and remdesivir, and is supporting the earlier development of multiple potential therapeutic treatments, vaccines, and diagnostic tests for COVID-19.