FDA Investigates Anti-Malaria Drug Chloroquine and Gilead’s Antiviral Remdesivir for COVID-19

By Patricia Van Arnum - DCAT Editorial Director

March 19, 2020

The US Food and Drug Administration (FDA) provided on update this week (March 19, 2020) on two potential treatments against the novel coronavirus (COVID-19), chloroquine, a drug already approved for treating malaria, lupus and rheumatoid arthritis, and remdesivir, an investigational antiviral drug from Gilead Sciences.

FDA says that it is working with other government agencies and academic centers that are investigating the use of the chloroquine to determine whether it can be used to treat patients with mild-to-moderate COVID-19. The FDA is evaluating whether the drug may potentially reduce the duration of symptoms, as well as viral shedding, which can help prevent the spread of disease. Studies are underway to determine the efficacy in using chloroquine to treat COVID-19.

Bayer, a producer of chloroquine, announced on March 19, 2020 that it is donating 3 million tablets of its drug, Resochin (chloroquine phosphate). Bayer says the drug appears to have broad spectrum antiviral properties and effects on the body’s immune response. New data from initial preclinical and evolving clinical research conducted in China, while limited, shows potential for the use of Resochin in treating patients with COVID-19 infection.

Currently not approved for use in the US, Bayer is working with appropriate agencies on an Emergency Use Authorization (EUA) for the drug’s use in the US. EUA allows the FDA to facilitate the availability and use of medical countermeasures needed during public health emergencies.

At the same time, the FDA says that it is working with manufacturers to increase production of chloroquine, if the drug is found to be effective, and will monitor potential supply-chain issues. “…[W]e will engage with domestic manufacturers to ramp up production of this product to mitigate any potential supply-chain pressures,” said Stephen Hahn, FDA Commissioner, in a March 19, 2020 statement. “If clinical data suggests this product may be promising in treating COVID-19, we know there will be increased demand for it. We will take all steps to ensure chloroquine remains available for patients who take it to treat severe and life-threatening illnesses such as lupus.”

Additionally, the US government continues to evaluate remdesivir, an investigational antiviral drug from Gilead Sciences. Last month (February 2020), the National Institutes of Health (NIH) began a randomized controlled trial for the treatment of COVID-19 patients with remdesivir. The FDA has been working with Gilead to find multiple pathways to both study the drug under the FDA’s investigational new drug requirements, and thus collect helpful data about the efficacy of the drug, as well as provide the drug to patients under emergency use. The FDA says it is continuing to make use of its expanded access program to allow the emergency use of this product for those patients, when appropriate. To date, the agency has already granted about 250 patients access to this product. The data collected from the expanded access program may contribute to the agency’s understanding of the drug, but controlled clinical trials are needed to determine if it safe and effective for the treatment of COVID-19 infection.

Source: FDA and Bayer