Tixagevimab / Cilgavimab (2) – Evusheld®

• Clinical trials
  • The PROVENT study (observation period November 2020 – February 2023) is a double-blind RCT comparing COVID-19 pre-exposure prophylaxis with tixagevimab/cilgavimab against placebo in adults who were unvaccinated at the start of the study and who, according to predefined inclusion criteria, are at increased risk of an inadequate immune response to vaccination or of SARS-CoV-2 infection.

Adults and adolescents aged 12 years and over weighing at least 40 kg for pre-exposure prophylaxis against COVID-19

• An additional benefit is not proven for adults and adolescents aged 12 years and over weighing at least 40 kg for pre-exposure prophylaxis against COVID-19.
• Overall, based on the study results presented, no conclusions can be drawn regarding the additional benefit of tixagevimab/cilgavimab compared with the appropriate comparator therapy in the patient population relevant to the benefit assessment, as it remains unclear whether the study patient population cited by the pharmaceutical manufacturer corresponds to the patient population relevant to the benefit assessment.
• Overall assessment
  • On balance, based on the study results submitted, no conclusions can be drawn regarding the additional benefit of tixagevimab/cilgavimab compared with the appropriate comparator therapy in the patient population relevant to the benefit assessment, as it remains unclear whether the study patient population used by the pharmaceutical manufacturer corresponds to the patient population relevant to the benefit assessment. An additional benefit is therefore not proven.

Courtesy translation only, please refer to the German original.