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This new agreement covers 1.25 million additional doses of the antibody cocktail containing casirivimab and imdevimab for the treatment of COVID-19.
Roche confirmed on Jan. 12, 2021 that the US Department of Health and Human Services (HHS) and the Department of Defense (DOD) have agreed to purchase additional supply of Regeneron Pharmaceuticals’ casirivimab and imdevimab antibody cocktail for use in non-hospitalized COVID-19 patients. The agreement is part of Operation Warp Speed.
Under this new agreement, the US government will purchase up to 1.25 million finished doses of the antibody cocktail by June 30, 2021. With Regeneron already supplying doses to treat approximately 300,000 people, the new agreement brings the total potential purchase to more than 1.5 million doses in the United States.
The efficacy and safety of casirivimab and imdevimab continue to be evaluated in clinical trials for the treatment of COVID-19 in certain hospitalized and non-hospitalized patients. The trials include an open-label trial (RECOVERY) of hospitalized patients in the United Kingdom and a trial for the prevention of COVID-19 in household contacts of infected individuals. In addition, lower doses of casirivimab and imdevimab are being studied with the aim of increasing supply and offering the therapy to more patients. To date, nearly 15,000 people have participated in clinical trials for this antibody cocktail, Roche said in a company press release.
Roche is collaborating with Regeneron to increase global supply of the cocktail and aims to have more than 2 million treatment doses available annually. Regeneron is responsible for the development and distribution of the treatment in the US, and Roche is primarily responsible for the development and distribution outside the US; the company is actively working with governments outside of the US on potential supply agreements. If approved, the companies will support access in low- and lower-middle-income countries through drug donations that will be made in partnership with public health organizations.
The US government said it will provide the additional doses from this new agreement at no cost to patients, though healthcare facilities may charge fees related to administration. The government will also continue to coordinate allocation of the antibody cocktail to state and territorial health departments.
“We are doing all we can to lessen the impact of the ongoing COVID-19 pandemic, and we remain committed to collaborating with Regeneron to increase supply of their antibody cocktail,” said Bill Anderson, CEO of Roche Pharmaceuticals, in the company press release. "Casirivimab and imdevimab will be critically important to help address the pandemic if approved, and we will continue to work with regulators and governments across the globe to bring the medicine to as many people as possible.”