Eli Lilly and Company announced an agreement with the US government to supply 300,000 vials of bamlanivimab (LY-CoV555) 700mg, an investigational neutralizing antibody for the treatment of mild to moderate coronavirus disease 2019 (COVID-19).
Bamlanivimab is a potent neutralizing IgG1 monoclonal antibody directed against the spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The investigational therapy is expected to block viral attachment and entry into human cells.
The agreement is contingent upon an Emergency Use Authorization (EUA) request submitted by the Company to the Food and Drug Administration (FDA) for bamlanivimab in early October. If the EUA is granted, the US government will accept and deliver the vials over 2 months with no out-of-pocket costs to patients for the medication, although health care facilities may charge a fee for the product’s administration. The agreement also provides the option for the US government to purchase up to an additional 650,000 vials through June 30, 2021.
The antibody therapy is currently being evaluated in the phase 2 BLAZE-1 study in adults with mild to moderate COVID-19 symptoms in an ambulatory setting; the phase 3 BLAZE-2 study for the prevention of COVID-19 in residents and staff of long-term care facilities; and the National Institutes of Health (NIH)-sponsored ACTIV-2 study in patients with recently diagnosed mild to moderate COVID-19. Results announced from BLAZE-1 showed that bamlanivimab may be beneficial as both a monotherapy and in combination with etesevimab, another investigational SARS-CoV-2 neutralizing antibody.
Recently, the Company announced that the ACTIV-3 study investigating bamlanivimab in hospitalized COVID-19 patients will be discontinued following a recommendation from the independent data and safety monitoring board stating that the treatment was unlikely to help patients with advanced disease.
“Supply agreements with governments, such as this one with the US government to meet Operation Warp Speed goals, are fundamental to enable the most widespread and equitable access to our potential therapy,” said David A. Ricks, Lilly’s chairman and CEO. “The US is experiencing a surge in COVID-19 cases and associated hospitalizations, and we believe bamlanivimab could be an important therapeutic option that can bring value to the overall health care system, as it has shown a potential benefit in clinical outcomes with a reduction in viral load and rates of symptoms and hospitalizations.”
For more information visit lilly.com.
- Lilly announces agreement with US government to supply 300,000 vials of investigational neutralizing antibody bamlanivimab (LY-CoV555) in an effort to fight COVID-19. [press release]. Indianapolis, IN: Eli Lilly and Company; October 28, 2020.
- Statement—NIH-sponsored ACTIV-3 trial closes LY-CoV555 sub-study. [press release]. Bethesda, MD: National Institutes of Health; Eli Lilly and Company; October 26, 2020.