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.
Daniel Skovronsky, Lilly’s chief scientific officer and president of Lilly Research Laboratories, said it is believed that the combination of two antibody treatments will be of use as new variants of COVID-19 are becoming more widely circulated in the United States.
“With this EUA for bamlanivimab and etesevimab together, there are more treatment options for patients at high risk for hospitalization and another layer of protection against the emergence of new viral variants,” Carl Hansen, president and chief executive officer of AbCellera, said in a statement.
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.
Indianapolis-based Eli Lilly noted that Phase II and Phase III studies have shown a range of doses of bamlanivimab alone and bamlanivimab and etesevimab together demonstrated consistent and similar clinical effects.
There are currently 100,000 doses of the combination therapy already available and Eli Lilly plans to manufacture an additional 150,000 doses throughout the first quarter of 2021. By mid-2021, the company expects to have about one million doses available due to an arrangement with Amgen. Eli Lilly said it will continue to supply bamlanivimab alone under the authorizations granted in various countries while continuing to accelerate manufacturing of etesevimab for use around the world.
“As COVID-19 cases, hospitalizations and subsequent deaths continue to rise, we are committed to working with the U.S. government to supply our antibody therapies for use by patients across the country,” Skovronsky added.
Eli Lilly is also assessing bamlanivimab in combination with a monoclonal antibody developed by Vir Biotechnology and GlaxoSmithKline. VIR-7831 is being studies in combination with bamlanivimab in low-risk patients with mild to moderate COVID-19. VIR-7831 is also being evaluated in the global Phase II/III COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early) trial for the early treatment of COVID-19 in adults at high risk of hospitalization.