Emergency Use Okayed for Hydroxychloroquine Sulfate to Treat COVID-19
While studies remain limited, hydroxychloroquine sulfate and chloroquine phosphate products have been touted as treatments for the novel coronavirus, including by President Donald Trump. Now, the FDA has issued an Emergency Use Authorization for the drug, which is being donated by manufacturers to the Strategic National Stockpile. Here is more information.
WASHINGTON, DC – An Emergency Use Authorization has been issued to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile to be distributed and prescribed by doctors to hospitalized adolescent and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible.
The Food and Drug Administration took the action after some studies showed promising results for the drug combination in novel coronavirus patients, although public health officials caution that more testing is needed. In addition, President Donald Trump weighed in on Twitter, touting the possible treatment.
At the end of March, the U.S. Department of Health and Human Services 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.
The agency suggests that those and other companies might donate additional doses and points out that companies have ramped up production to provide additional supplies of the medication to the commercial market.
As part of the EUA, fact sheets providing important information about using chloroquine phosphate and hydroxychloroquine sulfate in treating COVID-19 must be made available to healthcare providers and patients, including the known risks and drug interactions.
The Strategic National Stockpile, which does not regularly stock either drug, will work with the Federal Emergency Management Agency to ship donated doses to states.
The FDA may issue an EUA if 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. Public health officials point out that emergency access to a medical product under an EUA is separate from use of a medical product under an investigational drug application.
In response to the COVID-19 pandemic, 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, although this is the first drug-related emergency authorization.
The hope by federal officials is that the donated medications will help alleviate supply pressures for the drug, while the FDA also works with manufacturers of chloroquine and hydroxychloroquine to increase production to ensure the drugs remain available for patients dependent on them for treatment of malaria, lupus and rheumatoid arthritis.
Hydroxychloroquine, marketed as Plaquenil, is FDA-approved for the suppressive treatment and treatment of acute attacks of malaria due to Plasmodium vivax, P. malariae, P. ovale, and susceptible strains of P. falciparum. It is also indicated for the treatment of discoid and systemic lupus erythematosus, and rheumatoid arthritis. Chloroquine, also known as chloroquine phosphate, is an antimalarial medicine, sold under the brand name Aralen and as a generic medicine.
A French study, presented on YouTube and involving 24 patients, concluded that early indications suggest treatment with hydroxychloroquine would reduce the viral load, adding that results were even more promising with a hydroxychloroquine and azithromycin combination.
In addition, a letter published last month in Nature journal Cell Research concludes that chloroquine is “highly effective” in the control of 2019-nCoV infection in vitro for some animals and advises that it be assessed in human patients with the disease.
In response to the news, Trump wrote on Twitter on March 21, “HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains - Thank You! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents).”