March 28, 2020
The U.S. FDA has granted Emergency Use Authorization (EUA) for oral formulations of hydroxychloroquine sulfate and chloroquine phosphate to treat COVID-19 when prescribed and administered by a healthcare professional. Authorized use is limited to medication supplied from the Strategic National Stockpile.
Hydroxychloroquine and chloroquine are currently FDA approved to treat malaria, lupus, rheumatoid arthritis, and extraintestinal amebiasis (a protozoan infection). Emergency use for COVID-19 has been granted due to the current public health emergency and is based on limited in-vitro and anecdotal clinical data suggesting these drugs may be useful in treating the disease. However, their safety and efficacy have not been established in COVID-19 patients.
The FDA has issued the EUA to facilitate availability of the drugs to COVID-19 patients for whom participation in a clinical trial of the products is either not available or feasible. As new clinical data becomes available, the FDA will reassess the risk versus benefit of hydroxychloroquine and chloroquine in COVID-19 patients as appropriate.
Full conditions of the EUA can be found on the FDA’s website.