BARDA collaborated with the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and Army Contracting Command to modify an existing agreement with Eli Lilly and Company to increase the number of treatment courses of the investigational monoclonal antibody therapeutic, bamlanivimab, the federal government can purchase for use in treating non-hospitalized COVID-19 patients.
Under the flexible agreement, the government now can purchase more than 2 million additional treatment courses if needed, in addition to previous commitment to purchase 950,000 treatment courses. The contract modification ensures the therapeutic is not considered a scarce resource.
The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for bamlanivimab on Nov. 9. Healthcare providers administer the therapeutic through IV infusion to non-hospitalized patients with confirmed COVID-19 who are experiencing mild to moderate symptoms and are at high-risk for severe symptoms and hospitalization.
Lilly developed bamlanivimab without federal support. The monoclonal antibody that comprises the therapeutic was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19. Monoclonal antibodies, which mimic the human immune response, are produced outside of the body by a single clone of cells or a cell line with identical antibody molecules and then delivered to patients by infusion. The antibodies bind to certain proteins of a virus, reducing the ability of the virus to infect human cells.