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Paramyxoviruses for Tumor-targeted Immunomodulation: Design and Evaluation Ex Vivo
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Tixagevimab + Cilgavimab: First Approval

Susan J Keam1

  • 1Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. dru@adis.com.

Drugs
|June 21, 2022
PubMed

Tixagevimab 150 mg and cilgavimab 150 mg (EVUSHELDTM 150 mg + 150 mg solution for injection; tixagevimab + cilgavimab) is an intramuscular (IM) long-acting monoclonal antibody combination developed by AstraZeneca for the prevention and treatment of COVID-19. In March 2022, tixagevimab + cilgavimab was approved in the UK for pre-exposure prophylaxis of COVID-19 in adults who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 and who are unlikely to mount an adequate immune response to COVID-19 vaccination or for whom COVID-19 vaccination is not recommended, and in the EU for the prevention of COVID-19 in adults and adolescents aged ≥ 12 years and weighing ≥40 kg. In December 2021, tixagevimab + cilgavimab was granted Emergency Use Authorization by the US FDA for the pre-exposure prophylaxis of COVID-19 in adults and paediatric individuals (≥ 12 years of age and weighing ≥ 40 kg). This article summarizes the milestones in the development of tixagevimab + cilgavimab leading to this first approval for pre-exposure prophylaxis of COVID-19 in individuals who are not currently infected with SARS-CoV-2.

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