AbCellera gets EUA from US FDA for its antibody Bamlanivimab, along with Etesevimab for COVID-19
Lilly plans to manufacture more than 250,000 doses of the bamlanivimab and etesevimab therapy throughout Q1 2021, and up to a million doses by mid-2021
AbCellera announced that bamlanivimab (LY-CoV555) 700 mg, a human antibody discovered by AbCellera and developed with Eli Lilly and Company, administered with a second Lilly antibody, etesevimab (LY-CoV016) 1400 mg, has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) 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 hospitalisation. 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.
“The data show that bamlanivimab alone and bamlanivimab and etesevimab together are effective at reducing hospitalizations in high-risk COVID-19 patients, with consistent and similar efficacy across studies. 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,” said Carl Hansen, CEO and President of AbCellera.
The EUA is based on Phase 3 data from the BLAZE-1 trial, which were announced on January 26, 2021. In that study of more than 1,000 COVID-19 patients, those who received bamlanivimab and etesevimab together had a reduction in hospitalisations of 70 per cent and none died. Lilly plans to manufacture more than 250,000 doses of the bamlanivimab and etesevimab therapy throughout Q1 2021, and up to a million doses by mid-2021.