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U.S. Department of Health and Human Services

REGEN-COV

REGEN-COV Authorized by FDA for Post-Exposure Prophylaxis under Emergency Use Authorization

On July 30, 2021, the FDA authorized an additional use for the COVID-19 monoclonal antibody therapeutic REGEN-COV (casirivimab and imdevimab). The REGEN-COV Emergency Use Authorization (EUA) has been expanded to include post-exposure prophylaxis. FDA’s authorization of a therapeutic product for post-exposure prophylaxis is a significant advancement in the COVID-19 response that supplements vaccination for disease prevention.
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 On November 21, 2020, Regeneron Pharmaceuticals, Inc. received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the investigational monoclonal treatment REGEN-COV (casirivimab/imdevimab). The EUA allows healthcare providers to administer casirivimab/imdevimab together to treat mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or 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 coordinate distribution of this treatment.

HHS 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.

REGEN-COV Direct Ordering Process

HHS/ASPR is committed to the equitable and efficient distribution of REGEN-COV 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.

HHS/ASPR is managing the distribution of monoclonal antibody (mAb) products under EUA.  There is no shortage of supply of this treatment. As such, qualified treatment sites can order casirivimab/imdevimab from the drug’s sole distributor, Amerisource. Please see the direct ordering guide for further information and instructions. Direct orders for casirivimab/imdevimab are limited to 48 patient courses per site/per week, though sites with higher utilization can request additional courses. Treatment sites under the Special Projects for Equitable and Efficient Distribution (SPEED) of COVID-19 Outpatient Therapeutics program may also use the direct ordering process to obtain product.


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.

This authorization is reserved for emergency situations and is not the same as FDA approval or licensure.

Below is more information about the EUA for REGEN-COV.


This authorization is reserved for emergency situations and is not the same as FDA approval or licensure.

Below is more information about the EUA for REGEN-COV.


Related Resources

  • This page last reviewed: August 02, 2021