AstraZeneca’s Evusheld and Regeneron’s REGEN-COV Shelf Life Extended

The FDA has granted a 6-month extension of the shelf life of AstraZeneca’s monoclonal antibody drug, Evusheld (tixagevimab co-packaged with cilgavimab), from 18 months to 24 months.

The extension applies to all unopened vials of Evusheld that have been held in accordance with storage conditions laid out by the FDA in authorizing the drug for emergency use.

Evusheld is currently authorized for use as pre-exposure prophylaxis for prevention of COVID-19 in certain adult and pediatric individuals.

The agency has also extended the shelf life of Regeneron’s monoclonal antibody, REGEN-COV (casirivimab and imdevimab), from 24 months to 30 months. Currently, REGEN-COV isn’t authorized for use in the U.S. because it has not proved effective against the SARS-CoV-2 Omicron variant and its subvariants, but doses are being stored for possible use against future COVID-19 variants.