FDA Authorizes Shelf-Life Extension for Bamlanivimab From 18 to 24 Months

May 4, 2022

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 have issued joint communications regarding the availability of COVID-19 monoclonal antibody treatments currently authorized for emergency use in certain patients with COVID-19.

On May 4, 2022, FDA authorized an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bamlanivimab (see Table 1 below). Due to the high frequency of the Omicron variant, bamlanivimab and etesevimab are not currently authorized in any U.S. region. Therefore, these drugs may not be administered for treatment or post-exposure prevention of COVID-19 under the Emergency Use Authorization until further notice by the Agency. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to bamlanivimab and etesevimab, emerge and become prevalent in the United States. Retained product must be appropriately 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.

Evaluation of future extension of shelf-life for etesevimab is ongoing and an update regarding shelf-life extension for etesevimab is planned for November 2022. Therefore, in the interim, all etesevimab vials may be retained until the shelf-life extension evaluation is complete and posted, regardless of the current labeled expiry date or previously provided extension dates.

These recommendations apply to all unopened vials of bamlanivimab and etesevimab that have been held in accordance with storage conditions (refrigerated temperature at 2°C to 8°C (36°F to 46°F)) detailed in the authorized Fact Sheet for Health Care Providers or EUA 094 for bamlanivimab and etesevimab, administered together. Please contact COVID19Therapeutics@hhs.gov with any questions.

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