FDA, HHS Extend Shelf Life for Covid Pre-Exposure Prophylaxis Tx

The FDA and the HHS Assistant Secretary for Preparedness and Response (ASPR) announced an authorization extending the shelf-life of certain lots of tixagevimab and cilgavimab, a Covid-19 monoclonal antibody treatment, from 18 months to 24 months.

The combination antibody treatment, which is authorized as pre-exposure prophylaxis for Covid-19 in adults and children ages 12 and older (weighing at least 40 kg), can now be stored for an additonal 6 months past the currently labeled expiration date, so long as the vial remains unopened and can be stored in the proper conditions.

Per the treatment’s emergency use authorization, unopened vials of 150 mg/1.5 mL tixagevimab and 150 mg/1.5 mL cilgavimab must be stored at refrigerator temperatures (36-46°F, or 2-8°C) and in the original carton to protect the product from light.

FDA and HHS specified that the date identified on the vial and cartons of tixagevimab/cilgavimab noted in this authorization "reflects the original shelf-life of 18 months and does not reflect the extended 24-month shelf-life… If the batch number on the vial/carton is not included in this listing, the product is labeled with the correct expiration date."

Combination tixagevimab and cilgavimab, which is marketed by AstraZeneca as Evulshed, may only be used in adult and pediatric patients ages 12 and older weighing at least 40 kg who are not currently infected with SARS-CoV-2 and have not had a recent exposure; patients are only eligible if they have moderate to severe immunocompromise due to a medical condition or immunosuppresive medications, or those for whom Covid-19 vaccination is not recommended due to a history of severe adverse reactions.

For a full breakdown of the affected lots, original expiration dates, and updated products expiration dates, see the table provided at aspr.hhs.gov.