The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to a combination of Eli Lilly and AbCellera’s monoclonal antibody bamlanivimab and a second Eli Lilly antibody called etesevimab for mild to moderate COVID-19.
This combination therapy has been authorized for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab and etesevimab should be administered together via a single intravenous infusion as soon as possible after a positive COVID-19 test and within 10 days of symptom onset, Eli Lilly said in its announcement.
The FDA previously granted EUA to bamlanivimab in November for a similar indication. New protocols enable front-line clinicians to administer bamlanivimab alone and bamlanivimab and etesevimab together in as few as 16 minutes and 21 minutes, respectively. Previously, the infusion took about an hour. Bamlanivimab and etesevimab are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.
The EUA is based on Phase III data from the BLAZE-1 trial that showed the combination generated a reduction in hospitalizations of 70% of COVID patients. None of the patients who received the treatment died. The outcomes seen with the combination of bamlanivimab and etesevimab are consistent with the reduction in risk of hospitalization or ER visits seen with bamlanivimab alone, Eli Lilly said.
Both bamlanivimab and etesevimab are neutralizing recombinant human IgG1 monoclonal antibodies, and both target the SARS-COV-2 spike protein receptor binding domain to prevent entry into human cells. Bamlanivimab was first discovered by AbCellera from the blood of one of the first recovered COVID-19 patients in the United States. Lilly licensed etesevimab from Junshi Biosciences.