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Friday, January 15th, 2021

U.S. government buys extra 1.25M doses of Regeneron’s COVID-19 antibody therapeutic

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The U.S. Departments of Health and Human Services (HHS) and Defense (DoD) shored up the national supply of casirivimab and imdevimab this week with the purchase of another 1.25 million doses of Regeneron Pharmaceuticals, Inc.’s combo monoclonal antibody therapeutic for COVID-19.

Regeneron is still delivering the first approximately 300,000 doses of casirivimab and imdevimab under a previous contract established with the federal government’s Operation Warp Speed in July. The treatments are meant for patients with mild to moderate cases of COVID-19, and Regeneron’s treatment course is a combination of the pair. The additional doses are slated for delivery in the first half of this year.

“With COVID-19 cases continuing to rise, treating people with mild or moderate infections can help prevent hospitalizations, which will reduce the burden on healthcare systems,” Dr. Robert Kadlec, HHS Assistant Secretary for Preparedness and Response, said. “To ensure equitable and efficient distribution, we will continue coordinating with state and territorial health departments to get these additional therapeutics into the hands of healthcare providers quickly, with a focus on areas of the country currently hardest hit by the pandemic.”

The Biomedical Advanced Research and Development Authority (BARDA), in collaboration with DoD, put up $2.63 billion to fund the additional treatment courses. Allocations of the therapeutic will be divided up between states and territories proportionally based on confirmed COVID-19 cases and provided at no cost to patients.

Antibodies like the ones utilized here are a natural part of the human body, which bind with certain proteins of a virus and reduce its ability to infect human cells. However, Regeneron’s creation was made outside of the human body through a single clone of cells or a cell line producing identical antibody molecules, which are then delivered to patients either through infusion or injection. The treatment received an emergency use authorization from the U.S. Food and Drug Administration in November.

In an outpatient clinical trial, patients showed significant reductions in virus levels and required fewer medical visits. Evaluation by clinical trials continues. Dr. George Yancopoulos, president and chief scientific officer of Regeneron, notes that the combination nature of the therapeutic could also make it better able to maintain efficacy in the face of mutating versions of COVID-19.

“COVID-19 continues to sicken hundreds of thousands of Americans every day, and the people of Regeneron are committed to help,” Dr. Leonard S. Schleifer, president and CEO of Regeneron, said. “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.”