Public Health Emergency - Leading a Nation Prepared
On February 25, 2021, Eli Lilly and Company received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the investigational monoclonal antibody treatment bamlanivimab/etesevimab. The EUA allows healthcare providers to administer bamlanivimab/etesevimab 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 bamlanivimab/etesevimab, 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.
Learn more about other COVID-19 therapeutics, including:
HHS/ASPR is committed to the equitable and efficient distribution of bamlanivimab/etesevimab 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 Eli Lilly and Company, AmerisourceBergen (the distributor of the drug), state and territorial health departments, national healthcare and medical organizations and associations, and treatment sites to get bamlanivimab/etesevimab into the hands of healthcare providers.
HHS/ASPR is managing the distribution of mAb products under EUA. There is no shortage of supply of this treatment. As such, qualified treatment sites can order bamlanivimab/etesevimab from the drug’s sole distributor, Amerisource. Please see the direct ordering guard for further information and instructions. Direct orders for bamlanivimab/etesevimab 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.
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 may not be approved by the FDA for any use, or they may 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.
Below is more information about the EUA for bamlanivimab/etesevimab.
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