Outpatient Monoclonal Antibody Treatment for COVID-19 Made Available under Emergency Use Authorization
March 24, 2021
Update on COVID-19 variants and impact on bamlanivimab distribution
The Assistant Secretary for Preparedness and Response (ASPR) and the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services remain committed to ensuring you receive timely and transparent communication regarding the COVID-19 monoclonal antibody treatments that are currently authorized for emergency use in certain patients for the treatment of COVID-19.
Given the sustained increase in SARS-CoV-2 viral variants in the United States that are resistant to bamlanivimab administered alone, and the availability of other authorized monoclonal antibody therapies that are expected to retain activity to these variants, the U.S. Government, in coordination with Eli Lilly and Company, will stop the distribution of bamlanivimab alone starting today, March 24, 2021.
FDA recently updated the authorized
Fact Sheet for Healthcare Providers for the
bamlanivimab emergency use authorization (EUA). This update advised healthcare providers to consider the use of alternative authorized monoclonal antibody therapies that are expected to retain activity against circulating viral variants. Using an alternative authorized monoclonal antibody therapy may reduce the risk of treatment failure should a patient be infected with a SARS-CoV-2 viral variant that is resistant to bamlanivimab alone. Alternative monoclonal antibody therapies that are currently authorized for the same use include
bamlanivimab and etesevimab administered together and
REGEN-COV.
Health care providers should review the Antiviral Resistance information in Section 15 of the authorized Fact Sheets for each monoclonal antibody therapy available under an EUA for details regarding specific variants and resistance. Health care providers should also refer to the Centers for Disease Control and Prevention (CDC) website (https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-proportions.html) and information from state and local health
authorities regarding reports of viral variants of importance in their region to guide treatment decisions.
All treatment delivery sites will continue to be able to order bamlanivimab and etesevimab, to be administered together, or REGEN-COV from the authorized distributer following existing ordering and reporting procedures. Additionally, sites can order etesevimab alone to pair with the current supply of bamlanivimab the site has available. Monoclonal antibody therapies available under an EUA must be used in accordance with the terms and conditions for the respective authorization. The
Letters of Authorization may be accessed at:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
ASPR and FDA will continue to work with the CDC and the National Institutes of Health on surveillance of variants that may impact the use of the monoclonal antibody therapies authorized for emergency use. We will provide further updates and consider additional action as new information becomes available.
Please contact
COVID19Therapeutics@hhs.gov with any questions.
(Media inquiries should be directed to
ASPRMedia@hhs.gov.)
On November 9, 2020, Eli Lilly and Company received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the investigational monoclonal antibody treatment bamlanivimab. The EUA allows healthcare providers to administer bamlanivimab to treat mild to moderate COVID-19 in adults and pediatric patients (12 years 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, the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response (HHS/ASPR) is coordinating 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:
Bamlanivimab Direct Ordering Process
HHS/ASPR is committed to the equitable and efficient distribution of bamlanivimab 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, and national healthcare and medical organizations and associations to get bamlanivimab 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 bamlanivimab from the drug’s sole distributor, AmerisourceBergen.
For all other states, please see the direct ordering guide for further information and instructions. Direct orders for bamlanivimab 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 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.
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