U.S. Government Purchases $2.6 Billion COVID-19 Antibody ‘Cocktails’
The U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) announced they would purchase an additional supply of the casirivimab and imdevimab antibody cocktail for use by non-hospitalized COVID-19 patients.
The US government has said it will provide these doses at no cost to patients, though healthcare facilities may charge fees related to administration.
Under the new agreement with New York based Regeneron Pharmaceuticals, Inc., the US government would purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021, up to 1.25 million doses. This agreement’s potential value of up to $2.625 billion.
Regeneron is already supplying doses to treat approximately 300,000 people under a previous agreement. The total potential purchase will exceed 1.5 million doses.
Nearly 15,000 people have participated in casirivimab and imdevimab clinical trials.
Leonard S. Schleifer, M.D., Ph.D., President, and CEO of Regeneron, stated in a press release issued on January 12, 2021, "Tackling the COVID-19 pandemic will require a combination of public health measures, vaccines, and therapeutics. We are pleased to work with the U.S. government to supply our antibody cocktail as an important weapon in this fight."
The U.S. government said it would continue to coordinate the antibody allocation to state and territorial health departments. Patients, caregivers, and healthcare providers can find sites with COVID-19 antibody treatments through these links to the HHS or National Infusion Center Association locator tools, found on this webpage.
"Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems," added George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron.
"Additionally, as expected, the virus continues to mutate, with the possibility of developing resistance to any one antibody. The Regeneron cocktail of two antibodies, each targeting a different site on the virus, reduces the possibility of the virus becoming resistant."
The casirivimab and imdevimab antibody cocktail continue to be evaluated in clinical trials to treat COVID-19 in certain hospitalized and non-hospitalized patients, including the open-label RECOVERY trial of hospitalized patients in the United Kingdom and a study for the prevention of COVID-19 in household contacts of infected individuals.
The development and manufacturing of the antibody cocktail were funded in part with federal funds from the Biomedical Advanced Research and Development Authority, part of HHS, Office of the Assistant Secretary for Preparedness and Response.
Currently, the U.S. FDA’s authorized emergency use for non-hospitalized patients is 2,400 mg (1,200 mg casirivimab and 1,200 mg imdevimab) administered as a one-time infusion.
Furthermore, Regeneron is evaluating the safety and efficacy of a lower 1,200 mg dose (600 mg casirivimab and 600 mg imdevimab) of the antibody cocktail in this 'outpatient' setting.
The casirivimab and imdevimab ‘cocktail’ includes two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed specifically to block the infectivity of SARS-CoV-2, the virus that causes COVID-19.
The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science.
The clinical evidence from Regeneron's outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who are seronegative and/or who have a high viral load.
Regeneron stated it is collaborating with Roche to increase the global supply of casirivimab and imdevimab. Regeneron is responsible for the development and distribution of the treatment in the U.S., and Roche is primarily responsible for development and distribution outside the U.S.
Casirivimab and imdevimab injection is not authorized for use in patients hospitalized due to COVID-19, OR who require oxygen therapy due to COVID-19, OR who need an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19.
These antibody therapies require a drug order (similar to a prescription) from a Health Care Provider (HCP) for eligible patients. HCPs must verify their patients’ eligibility and confirm the availability of doses at an authorized infusion site before they refer a qualified patient to schedule an appointment to receive treatment at an authorized infusion site.
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.
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