The Food and Drug Administration (FDA) has authorized an extension to the shelf-life of 2 monoclonal antibody therapies: REGEN-COV® (casirivimab and imdevimab) and Evusheld (tixagevimab co-packaged with cilgavimab).

The shelf-life of REGEN-COV and the individually cartoned vials of casirivimab and imdevimab has been extended from 24 to 30 months, stored at 2 to 8°C (36°F to 46°F) for specific lots and applies to all unopened vials that have been held according to the manufacturer’s storage conditions. Updated expiry dates by batch number can be found here.

Due to the high frequency of the Omicron variant, REGEN-COV is currently not authorized for emergency use in any US region for treatment or postexposure prophylaxis of COVID-19. The US government has recommended the product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to REGEN-COV, emerge and become prevalent in the US.


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The shelf-life of Evusheld has been extended from 18 to 24 months stored at 2 to 8°C (36°F to 46°F) for specific lots and applies to all unopened vials that have been held according to the manufacturer’s storage conditions. Updated expiry dates by batch number can be found here

Evusheld is currently authorized for emergency use for preexposure prophylaxis of COVID-19 in certain adult and pediatric patients.

References

  1. Important update: FDA authorizes shelf-life extension for REGEN-COV from 24 months to 30 months. News release. HHS Office of the Assistant Secretary for Preparedness & Response. Accessed June 29, 2022. https://aspr.hhs.gov/COVID-19/Therapeutics/updates/Pages/important-update-27June2022.aspx
  2. Important update: shelf-life extension of Evusheld under Emergency Use Authorization. News release. HHS Office of the Assistant Secretary for Preparedness & Response. Accessed June 29, 2022. https://aspr.hhs.gov/COVID-19/Therapeutics/updates/Pages/important-update-28June2022.aspx

This article originally appeared on MPR