AbCellera antibody gets US FDA EUA as monotherapy for COVID-19 treatment
AbCellera’s partner, Eli Lilly and Company, will supply the US government with 300,000 doses of bamlanivimab for allocation to high-risk patients
AbCellera announced that bamlanivimab (LY-CoV555) 700 mg, a human antibody developed through AbCellera’s collaboration with Eli Lilly and Company (Lilly), has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA). Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalisation. The EUA is based on data from BLAZE-1, a randomized, double-blind placebo-controlled Phase 2 study in patients with recently diagnosed mild to moderate COVID-19 in the outpatient setting. Patients treated with bamlanivimab showed reduced viral load and rates of symptoms and hospitalisation. Details regarding the EUA and Lilly’s plans to make COVID-19 therapies broadly available to patients, including its agreement to provide the U.S. government with 300,000 doses, can be found here.
“We commend the Lilly team for their tireless efforts to combat COVID-19 and for starting antibody manufacturing at risk in advance of clinical results. Because of this, there is now an opportunity to have a near-term impact against COVID-19, manufacturing up to one million doses of bamlanivimab to patients before the end of the year,” said Carl Hansen, CEO of AbCellera.
Bamlanivimab was the first monoclonal antibody therapy for COVID-19 to enter human testing in the US and is currently undergoing multiple Phase 1, 2 and 3 clinical trials. Bamlanivimab was discovered from the blood of a recovered COVID-19 patient by AbCellera, scientists at the Vaccine Research Center at National Institute of Allergy and Infectious Diseases (NIAID) and Lilly.
AbCellera’s COVID-19 response was based on capabilities developed over the past two years as part of the Defense Advanced Research Projects Agency (DARPA) Pandemic Prevention Platform (P3) program. The goal of the P3 program is to establish a robust technology platform for pandemic response capable of developing field-ready medical countermeasures within 60 days of isolation of an unknown viral pathogen.