FDA Permits Emergency Use of Experimental Treatments for COVID-19

March 30, 2020

Chloroquine and hydroxychloroquine have been authorized to treat hospitalized patients with COVID-19.

Hydroxychloroquine sulfate and chloroquine phosphate have been granted Emergency Use Authorization by the FDA for emergency use in hospitalized patients with COVID-19, according to the agency.1

The EUA allows the US Biomedical Advanced Research and Development Authority (BARDA) to distribute donated hydroxychloroquine sulfate and chloroquine phosphate products to physicians. Physicians are permitted to use supplies of chloroquine and hydroxychloroquine from the Strategic National Stockpile (SNS) to treat adults and adolescents who weigh 50 kg or more and  have been hospitalized and are unable to participate in a clinical trial.1,2

According to the Department of Health and Human Services (HHS), it has accepted 30 million doses of hydroxychloroquine sulfate donated by Sandoz and 1 million doses donated by Bayer Pharmaceuticals to the SNS.2

Hydroxychloroquine sulfate and chloroquine phosphate are both approved by the FDA for other medical conditions, such as malaria, lupus, and rheumatoid arthritis, but not for COVID-19.

In a letter to BARDA, FDA chief scientist Denise M. Hinton cited the potential of SARS-CoV-2 to cause severe or life-threatening respiratory illness, the totality of scientific evidence at the FDA’s dispense, and the lack of current approved treatments as reasons for the authorization of chloroquine phosphate and hydroxychloroquine sulfate for treating COVID-19.3

The letter establishes the FDA’s first EUA for a therapeutic product.3

The FDA fact sheet for health care workers offering either hydroxychloroquine or chloroquine to a patient specifies that optimal dosing and duration of treatment is not known, and that suggested parameters will be updated as data from clinical trials surfaces. However, the FDA recommends 800 milligrams on the first day of treatment, and then 400 milligrams daily for 4 to 7 subsequent days.1

In her letter to BARDA, Hinton concluded that chloroquine phosphate and hydroxychloroquine sulfate “may be effective for the treatment of COVID-19,” and meets FDA safety criteria.3

The letter also stipulates that the SNS will record the distribution of the drugs for COVID-19 treatment, and HHS will distribute the EUA terms to public health authorities; it delegates numerous other responsibilities to SNS and HHS as well.3

FDA’s fact sheet warns of adverse effects related to cardiac issues, hypoglycemia, and renal impairment, among others, as well as potential drug interactions. The fact sheet states that health care providers are responsible for reporting adverse events to the FDA.1

To date, no treatments for COVID-19 have been approved by the FDA.

References:

1. Fact sheet for health care providers. FDA website. https://www.fda.gov/media/136537/download. Accessed March 30, 2020.
2. HHS accepts donations of medicine to Strategic National Stockpile as possible treatments for COVID-19 patients [news release]. HHS’ website. https://www.hhs.gov/about/news/2020/03/29/hhs-accepts-donations-of-medicine-to-strategic-national-stockpile-as-possible-treatments-for-covid-19-patients.html. Accessed March 30, 2020.
3. Request for emergency use authorization for use of chloroquine phosphate or hydroxychloroquine sulfate supplied from the strategic national stockpile for treatment of 2019 coronavirus disease. FDA website. https://www.fda.gov/media/136534/download. Accessed March 30, 2020.