The Food and Drug Administration granted emergency-use authorization Saturday evening to Regeneron Pharmaceutical for the antibody cocktail that President Donald Trump was given after he was diagnosed with COVID-19 back in early October.
The treatment consists of two antibodies, casirivimab and imdevimab, that when combined have shown promise in treating COVID-19 patients with mild to moderate cases, but who “are at high risk for progressing to severe COVID-19,” the FDA said Saturday evening.
Dr. Stephen Hahn, commissioner of the FDA, said that the antibody cocktail “may help outpatients avoid hospitalization and alleviate the burden on our health care system.”
The FDA has not granted emergency authorization for the drug to be used for patients who have already been hospitalized or are receiving oxygen therapy due to COVID-19.
“Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation,” notes the agency.