The Departments of Defense and Health and Human Services are buying 300,000 doses of a COVID-19 antibody treatment made by Eli Lilly -- a therapy federal researchers said Monday shows no improvement in hospitalized patients, but the company maintains could help treat patients with milder cases.
Under Operation Warp Speed, the Trump administration's initiative to fast-track a coronavirus vaccine and treatments, DoD and HHS are buying 300,000 doses of bamlanivimab, a monoclonal antibody therapy, for an initial purchase price of $375 million, according to the Pentagon.
The intention is for the intravenous treatment, also known as LY-CoV555, to be distributed to states and local health departments for outpatient care once the Food and Drug Administration authorizes its use.
Earlier this week, Eli Lilly ended its clinical trial of bamlanivimab for patients hospitalized for COVID-19 after researchers with the National Institutes of Health concluded it didn't appear to help them recover.
The study had been paused Oct. 13 because of a potential safety concern. But after investigating the issue, NIH researchers ruled the therapy posed no significant safety risk for patients. They did conclude, however, that it was "unlikely to help hospitalized COVID-19 patients recover."
Company officials maintain, however, that the therapy shows promise for those with milder cases of COVID-19, and research continues on treating patients with less advanced COVID-19.
According to Eli Lilly, while there is insufficient evidence that the treatment improved clinical outcomes in hospitalized patients, researchers remain confident that based on data from other studies, it "may prevent progression of disease for those earlier in the course of COVID-19."
"We believe bamlanivimab could be an important therapeutic option that can bring value to the overall healthcare system, as it has shown a potential benefit in clinical outcomes with a reduction in viral load and rates of symptoms and hospitalizations," Lilly chairman and CEO David Ricks said in a release Wednesday.
The FDA could issue an emergency-use authorization that would allow the therapy to be used as an outpatient treatment, depending on the outcome of the ongoing studies.
"More good news about COVID-19 therapeutics is constantly emerging, and the Trump Administration's commitment to supporting potentially lifesaving therapeutics will help deliver these products to American patients without a day's delay," HHS Secretary Alex Azar said in a release announcing the purchase.
The contract -- a collaboration with the Biomedical Advanced Research and Development Authority, or BARDA, the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command -- is worth up to $812.5 million, with the federal government maintaining the option to buy up to 650,000 additional doses over the next two years.