FDA

Due to the emergence of Omicron subvariants that evade the effect of this drug’s two monoclonal antibodies, FDA withdrew the EUA (1/26/23).

The FDA issued an Emergency Use Authorization (EUA) permitting the emergency use of tixagevimab/cilgavimab for pre-exposure (PrEP) of COVID-19 in adults and pediatric patients (≥12 years of age and at least 40kg) who are not currently infected with SARS-CoV-2, have not had recent exposure to SARS-CoV-2.

AND

• Have moderate to severe immune-compromised status due to a medical condition or immunosuppressive medications/treatment and may not mount an adequate immune response from COVID-19 vaccination

OR

• For whom vaccination with any available COVID-19 vaccine, according to the approved/authorized schedule, is not recommended due to a history of severe adverse reaction (e.g. severe allergic reaction) to a COVID-19 vaccine and/or vaccine component

Tixagevimab/cilgavimab is NOT indicated for:

• The treatment of COVID-19 disease
• Post-exposure (PEP) of COVID-19 in individuals who have been exposed to someone infected with SARS-CoV-2

PrEP is not a substitute for vaccination in individuals for whom vaccination is recommended. For individuals who have been vaccinated, tixagevimab/cilgavimab should be administered 2 weeks after vaccine administration.