This is the second authorization for the monoclonal antibody therapy globally. Earlier this month, on November 9, the US Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for bamlanivimab 700 mg.
In both Canada and the US, bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older who weigh at least 40 kg with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization.
The US drug developer aims to manufacture up to one million doses of bamlanivimab by the end of 2020, for use worldwide through early next year. It expects supply to increase substantially from the first quarter of 2021.
Last week Lilly announced that it has forged a longer-term partnership with South Korea’s Samsung Biologics to expand the supply of the COVID-19 neutralizing antibody treatments.
“This agreement with Samsung supplements Lilly’s own internal manufacturing capacity and greatly expands our ability to deliver Lilly antibody therapies to patients around the world,” commented David A Ricks, Lilly’s chairman and CEO.
Lilly said it is in discussions with global regulators to make bamlanivimab available around the world, with it focused on areas with the highest disease burden. The pharma giant is also pursuing authorization in countries such as India, Brazil, Russia and across Europe.
Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19.
The therapy emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19.
Lilly said its scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the US National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first US patients who recovered from COVID-19.
Lilly has completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628).
A Phase 2 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing.
A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is also ongoing.
In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.