Evusheld long-acting antibody combination recommended by CHMP for approval in the EU for the pre-exposure prophylaxis of COVID-19.
AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.
People not adequately protected by a COVID-19 vaccine may particularly benefit from pre-exposure prophylaxis with Evusheld. This includes about three million people in the EU who are immunocompromised or being treated with immunosuppressive medicines.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on a review of Evusheld data, including results from the PROVENT Phase III pre-exposure prophylaxis trial, which showed a 77% reduction in the risk of developing symptomatic COVID-19 compared to placebo at the primary analysis and an 83% reduction at a six month median analysis, with protection from the virus continuing for at least six months. Evusheld was generally well-tolerated in the trial.
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