The U.S. Food and Drug Administration (FDA) Friday revoked the emergency use authorization (EUA) for bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients who are at high risk of disease progression or hospitalization.
Please see the full FDA statement here.
REGEN-COV as well as bamlanivimab and etesevimab (administered together) continue to be available under EUA. There is no shortage of monoclonal antibody product. Sites that are administering monoclonal antibodies can order bamlanivimab and etesevimab, etesevimab to pair with the current supply of bamlanivimab that the site has available, or REGEN-COV from the authorized distributer using the direct ordering process.
mAb Direct Ordering
Healthcare institutions now have the ability to quickly order the monoclonal antibody therapies through direct ordering from AmerisourceBergen Corporation (ABC), the drugs sole distributer. There is no shortage in supply of these drugs, and the federal government has enough on hand to meet the needs of interested treatment facilities. The therapies remain free of charge to requesting sites.
Questions regarding the direct order process:
Furthermore, the federal government and AmerisourceBergen permit the ordering of courses of etesivimab to pair with existing bamlanivimab supply. HHS and ABC have established a soft cap of 48 patient courses per site; however, high throughput sites are encouraged to order additional courses.
NIH Recommendations
The Office of the Assistant Secretary for Preparedness and Response (ASPR) remains committed to ensuring providers receive timely and transparent communication regarding monoclonal antibody treatments currently authorized for emergency use in certain patients for the treatment of COVID-19.
Providers should note recent updates to the National Institutes of Health (NIH) COVID-19 Treatment Guidelines published on April 8, 2021, on all three authorized COVID-19 monoclonal antibodies. The guidelines now include the following recommendations:
- For use of Bamlanivimab 700 mg plus etesevimab 1,400 mg (AIIa) and Casirivimab 1,200 mg plus imdevimab 1,200 mg (AIIa)
- Against use of bamlanivimab monotherapy (AIII)
The full NIH update is available here.
On March 24, 2021, the U.S. Government paused the distribution of bamlanivimab alone given the sustained increase in SARS-CoV-2 viral variants in the United States that are resistant to bamlanivimab administered alone.
Considering the updated recommendations from the NIH, ASPR recommends that sites that only have bamlanivimab, and are administering monoclonal antibodies, order either etesevimab to pair with the current supply of bamlanivimab that the site has available or REGEN-COV from the authorized distributer using the direct ordering process.
REGN-COV Packaging
Please be advised that effective immediately, the monoclonal antibody treatment of casirivimab and imdevimab from Regeneron Pharmaceuticals is now being shipped in 11.1 ml vials. The 2.5 ml vials will no longer be shipped. One treatment course contains two vials, one of casirivimab and one of imdevimab, and they will be packaged and bagged together.
Both Eli Lilly and Regeneron combo therapies, as stated above, are recommended for use and available at no cost.
mAb Locator Options
(Please note that our SOM therapeutics page links directly to the NICA locator)
It is important for hospitals to note that the mAb medications being provided are intended to serve the broad local community. This could include federally qualified health centers, independent outpatient clinics, free-standing infusion centers, long-term care facilities, home care settings and other sites. Any outpatient clinic, free-standing infusion center or home care provider interested in obtaining and administering monoclonal antibody therapies are encouraged to contact Jason Smith.
The US Department of Health and Human Services has launched an online ‘Therapeutics Distribution Locations’ map that can be viewable here.
Additionally, the National Infusion Center Association (NICA) has published a public facing "COVID-19 Antibody Therapy Locator" tool. Sites currently administering mAb are encouraged to visit this site, locate their facility and claim/verify content for accuracy to ensure that treatment is accessible for both prescribers and the public.
