FDA Issues Emergency Approval for Anti-Malaria Drugs

The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to BARDA 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.
 
The U.S. Department of Health and Human Services (HHS) has accepted 30 million doses of hydroxychloroquine sulfate donated by Sandoz, the Novartis generics and biosimilars division, and one million doses of chloroquine phosphate donated by Bayer Pharmaceuticals, for possible use in treating patients hospitalized with COVID-19 or for use 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.
 
HHS’ Office of the Assistant Secretary for Preparedness and Response (ASPR) worked with colleagues within HHS, the companies, the Department of State, and the Department of Homeland Security to secure the donated shipments. 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 EUA requires that fact sheets that provide important information about using chloroquine phosphate and hydroxychloroquine sulfate in treating COVID-19 be made available to health care providers and patients, including the known risks and drug interactions.
 
The SNS, managed by ASPR, will work with the Federal Emergency Management Agency (FEMA) to ship donated doses to states. The SNS does not regularly stock either drug.
 
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.
 
When the Secretary of Health and Human Services declares that issuance of an EUA is appropriate, the FDA has the regulatory emergency use authority to facilitate access to unapproved medical countermeasures or unapproved uses of approved medical countermeasures needed to prepare for and respond to chemical, biological, radiological and nuclear threats.
 
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. Emergency access to a medical product under an EUA is separate from use of a medical product under an investigational drug application.
 
The FDA has issued an EUA for multiple diagnostics, for several other medical devices such as respiratory devices and a system for decontaminating them to allow for their reuse, and ventilators and ventilator equipment for the COVID-19 response. This is the first EUA for a drug related to the COVID-19 response.
 
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.
 
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.

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