FDA announces new emergency use authorization for COVID-19 antibody treatment

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

The emergency authorization for the new drug, called bebtelovimab, is for the treatment of "mild to moderate COVID-19 in adults and pediatric patients,” the FDA said Friday

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

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

The new treatment is not a substitute for vaccination in individuals for whom a vaccination and a booster dose are recommended," the FDA also said.