FDA Announces New Emergency Use Authorization for COVID Antibody Treatment

The U.S. Food and Drug Administration this week announced an emergency use authorization for a new monoclonal antibody treatment against COVID-19, a course which it said would be effective against the waning omicron variant of the virus.

The EUA for the new drug, called bebtelovimab, “is for the treatment of mild to moderate COVID-19 in adults and pediatric patients,” the FDA said in an announcement.

This includes patients “with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.”

Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, said the authorization is “an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge.”