Shelf-Life Extension of Etesevimab Under the Emergency Use Authorization for Bamlanivimab and Etesevimab Administered Together

October 22, 2021

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 are committed to transparent communication regarding the COVID-19 monoclonal antibody treatments currently authorized for emergency use in certain patients with COVID-19.

FDA and ASPR are announcing the authorization of an extension to the shelf-life from 12 months to 18 months for the refrigerated Eli Lilly monoclonal antibody, etesevimab, which is currently authorized for emergency use only when administered together with bamlanivimab.  As a result of this extension, unopened vials of etesevimab, injection, 700 mg/20 mL, should be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F), and may be stored for an additional 6 months from the labeled date of expiry (See Table 1 below). FDA granted this extension following a thorough review of data submitted by Eli Lilly. This extension applies to all unopened vials of etesevimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for Emergency Use Authorization (EUA) 094 for bamlanivimab and etesevimab, administered together.

The etesevimab, authorized to be administered together with bamlanivimab under the EUA, has fixed expiration dates on the label of each vial and carton. The date identified on the vial and carton reflects the original shelf-life expiry of 12 months and does not reflect the extended 18-month shelf-life expiry. The table below provides the updated expiry, by batch, for distributed etesevimab.

Table 1: Extended Expiry Dating for Etesevimab Authorized under EUA 94 (Bamlanivimab and Etesevimab Administered together)