By R. Mitchell –
As part of the Trump Administration’s goal of delivering life-saving vaccines and therapeutics in record time through Operation Warp Speed, the U.S. Department of Health and Human Services (HHS) and Department of Defense (DOD) today announced an agreement with Eli Lilly and Company to purchase the first doses of the company’s COVID-19 investigational antibody therapeutic bamlanivimab, also known as LY-CoV555. These doses will be available for patient care if the U.S. Food and Drug Administration (FDA) authorizes the use of the therapeutic, as outlined in agency guidance.
“This agreement with Eli Lilly is part of Operation Warp Speed’s efforts to position the federal government to distribute potential therapeutics, allowing faster distribution if trials are successful,” said HHS Secretary Alex Azar. “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.”
The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command to provide $375 million for an initial purchase of 300,000 doses of bamlanivimab 700 mg from Lilly over the next two months. Under the agreement, the federal government can purchase up to 650,000 additional doses through the end of June 2021 for up to an additional $812.5 million.
If the FDA authorizes use of the drug, the federal government will allocate the doses to state and territorial health departments which, in turn, will determine which healthcare facilities receive the intravenous (IV) infusion drug for use in outpatient care. These government-purchased doses would become available to the American people at no cost, although as is customary with such government-purchased products, healthcare professionals could charge for administering the medicine.
Bamlanivimab currently is being evaluated in phase 3 clinical trials funded by the company in addition to clinical trials as part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership led by the National Institutes of Health with funding and other support from BARDA. ACTIV is part of a coordinated research strategy to prioritize and speed development of the most promising treatments and vaccines.
FDA is reviewing bamlanivimab as a possible treatment for COVID-19 in outpatients. The monoclonal antibody used in the drug were 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 system, 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 injection or infusion. The antibodies bind to certain proteins of a virus, reducing the ability of the virus to infect human cells.
About Operation Warp Speed (OWS):
OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
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