Eli Lilly’s Combination Antibody Drug for COVID-19 Granted FDA Emergency Use Authorization

Eli Lilly and Company’s (Indianapolis, Ind, USA) neutralizing antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) administered together have been authorized for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are high risk for progression to severe COVID-19.

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for investigational bamlanivimab 700 mg and etesevimab 1400 mg together 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. The EUA is based on Phase 3 data from the BLAZE-1 trial, announced January 26, 2021, which demonstrated bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70%. These data replicate earlier results in a much larger group of patients. Additionally, the outcomes seen with bamlanivimab and etesevimab together are consistent with the reduction in risk of hospitalization or ER visits seen with bamlanivimab alone.

The FDA has authorized that 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. In addition, the FDA has authorized infusion times for bamlanivimab alone and bamlanivimab and etesevimab together to be as short as 16 or 21 minutes, respectively – a significant reduction from the previously authorized time of 60 minutes. This decision has been made in response to feedback received from front-line nurses and doctors administering these infusions and are aimed at reducing the burden on the healthcare system.

"Bamlanivimab alone under emergency use authorization has already provided many people with an early treatment option that could prevent hospitalizations and we are excited to now add an additional therapeutic option with a similar demonstrated clinical benefit," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "Additionally, with the risk of resistance emerging as various strains of the virus arise, bamlanivimab and etesevimab together could potentially allow efficacy against a broader range of naturally occurring SARS-CoV-2 variants as these new strains spread around the world."

“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. “As part of our Coronavirus Treatment Acceleration Program, the FDA uses every resource at our disposal to make treatments such as these monoclonal antibodies available while continuing to study their safety and effectiveness.”

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