FDA authorizes new combination antibody therapy

The Food and Drug Administration yesterday authorized administering the monoclonal antibodies bamlanivimab and etesevimab together to treat patients 12 and older with mild-to-moderate COVID-19 who are at high risk for progressing to severe disease but not hospitalized or on oxygen therapy. Issued to Eli Lilly and Co., the emergency use authorization also authorizes the treatment for patients 65 or older with certain chronic medical conditions. In a clinical trial involving 1,035 non-hospitalized adults, a single infusion of the two antibodies reduced hospitalizations and deaths related to COVID-19, although its safety and effectiveness are still being evaluated. The combination therapy also reduced the risk of resistant viruses developing during treatment when compared with bamlanivimab alone, which received an EUA last November. For more information, see the fact sheet for health care providers.

“The data supporting this emergency authorization add to emerging evidence that points to the clinical utility of neutralizing antibodies for the treatment of COVID-19 in certain patients,” said Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research.