Casirivimab/Imdevimab

ASPR's Portfolio of Outpatient Monoclonal Antibody Treatment for COVID-19 Made Available Under Emergency Use Authorization

On November 21, 2020, Regeneron Pharmaceuticals, Inc. received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the investigational treatment cocktail consisting of 2 monoclonal antibodies, casirivimab and imdevimab. The EUA allows healthcare providers to administer casirivimab/imdevimab to non-hospitalized patients with confirmed COVID-19 who are experiencing mild to moderate symptoms and are at high-risk for severe symptoms and hospitalization. In alignment with the terms of the EUA for casirivimab/imdevimab, the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response (HHS/ASPR) will oversee allocation of this therapeutic and coordinate its distribution.

HHS/ASPR's Biomedical Advanced Research and Development Authority is sponsoring the development of a number of therapeutic products that have been granted EUA by the FDA and/or are being made available under FDA’s expanded access program for the treatment of COVID-19.

Learn more about other COVID-19 therapeutics, including:

• Veklury (remdesivir)
• Bamlanivimab
• Convalescent plasma

Casirivimab/Imdevimab Allocation and Distribution Process

HHS/ASPR is committed to the equitable and efficient distribution of casirivimab/imdevimab with the goal of reaching as many patients as possible, no matter where in the country they live and regardless of their income. HHS is coordinating with Regeneron Pharmaceuticals, Inc., AmerisourceBergen (the sole distributor of the drug), state and territorial health departments, and national healthcare and medical organizations and associations to get casirivimab/imdevimab into the hands of healthcare providers quickly, with a focus on areas of the country hardest hit by the pandemic.

In general, a state/territory’s percentage of the country’s total number of confirmed COVID-19 patients and the total number of confirmed hospitalized patients during a seven-day reporting period will equal that state/territory’s percentage of available casirivimab/imdevimab for a given distribution week. Once allocation amounts are determined, HHS/ASPR will notify state/territorial health departments of their casirivimab/imdevimab allocations. State/territorial health departments, not the federal government, then determine how much casirivimab/imdevimab each health care facility within their respective jurisdictions can receive based on the state/territory’s total allocation. Health care facilities identified by their respective state/territorial health department to receive an allocation of casirivimab/imdevimab will coordinate shipping directly with the distributor, AmerisourceBergen.

In addition to allocations to states and territories, the therapeutics are being allocated to the Department of Defense, the Veterans Health Administration, the Indian Health Service, the Bureau of Prisons, the Department of State, and the National Institutes of Health for distribution within those healthcare systems.

Allocation of  Casirivimab/Imdevimab by Jurisdiction

Casirivimab/imdevimab is allocated by the federal government to states, territories and federal entities on a weekly basis. Allocations will be made in two phases. During Phase 1, states/territories will allocate casirivimab/imdevimab to hospitals and hospital-affiliated locations. Upon further assessment of drug administration requirements, Phase 2 of allocations will include expanded distribution to additional outpatient facilities.

To find out how much casirivimab/imdevimab has been allocated to specific states, territories, and federal entities, see the casirivimab/imdevimab allocation dashboard. This dashboard will be updated each distribution week until the FDA either approves the drug or issues a revised EUA indicating U.S. government involvement in the allocation and distribution process is no longer required. This may occur when the supply of the product meets the demand from the commercial marketplace.

About Emergency Use Authorizations

In certain types of emergencies, the HHS Secretary may issue a determination and declaration under the Food Drug and Cosmetic Act that permits the FDA to issue EUAs to facilitate access to medical countermeasures (drugs, biologics, vaccines, and devices) that can be used to diagnose, treat, or prevent a serious disease or condition in a public health emergency.

Products authorized for use in this way might not be approved by the FDA for any use, or they might be approved for other uses but not for the emergency use. The FDA decides whether the use of the product is likely to be more helpful than harmful for the emergency use; i.e., the agency determines that the known and potential benefits of the medical products for their intended uses outweigh their known and potential risks. This authorization is reserved for emergency situations and is not the same as FDA approval or licensure.