FDA Issues EUA for Monoclonal Antibody Treatment of COVID-19

On February 9, 2021, the U.S. Food and Drug Administration (FDA) granted Eli Lilly and Company an emergency use authorization (EUA) for simultaneous administration of monoclonal antibodies bamlanivimab and etesevimab to treat COVID-19 patients who meet specific criteria. The agency says clinical trial results indicate, when used jointly, bamlanivimab and etesevimab can reduce rates of hospitalization and death among patients with the virus.

Under the EUA, 700 milligrams of bamlanivimab and 1,400 milligrams of etesevimab must be administered together after dilution by intravenous infusion only to patients who meet specific criteria. The scope of the authorization includes, but is not limited to, the following:

Use in patients 12 years of age and older who weigh at least 40 kg and are experiencing mild to moderate coronavirus disease with a high risk for progressing to severe COVID-19 and/or hospitalization. Additionally, patients should have a positive SARS-CoV2 viral test result.

Those with known hypersensitivity to the ingredients in either monoclonal antibody are excluded from treatment. The FDA says prescribers are responsible for completing mandatory reporting of all medication errors and adverse events related to the use of bamlanivimab and etesevimab within 7 days from the onset of the event. A fact sheet issued by FDA outlines detailed directions for physicians on limitations of use, preparation and administration, potential adverse reactions, dosing, reporting requirements and more.

MLMIC continues to support our insureds in their ongoing efforts to address the COVID-19 pandemic and its treatment. Please contact our Underwriting Department for any questions you may have related to coverage for the use of any medication/device/etc. in these efforts.

Additionally, our policyholders are advised to monitor emerging FDA information pertaining to testing, transmission and treatment of COVID-19. MLMIC has assembled a number of critical resources to support New York physicians as they navigate the pandemic. This information, which includes the latest developments in medicine and government, can be accessed on our website.