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Evusheld Positive EU CHMP Opinion
Evusheld Positive EU CHMP Opinion.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 9754F\n AstraZeneca PLC\n 24 March 2022\n \n \n \n \n 24 March 2022 18:00 GMT\n \n \n \n \n \n \n Evusheld\n \n \n long-acting antibody combination recommended for approval \n \n \n \n in the EU for the pre-exposure prophylaxis (prevention) of COVID-19 \n \n \n \n \n \n Recommendation based on Phase III PROVENT trial showing \n \n \n a significant reduction in the risk of developing symptomatic COVID-19, \n \n \n with protection lasting at least six months \n \n \n \n \n \n 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. \n \n \n \n \n \n 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.1\n \n \n \n \n \n \n \n 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.2-4Evusheld was generally well-tolerated in the trial.2-4\n \n \n \n \n \n Hugh Montgomery, Professor of Intensive Care Medicine at University College London, UK and Evusheld investigator said:\n \"Despite the success of vaccinations, we still need additional measures to prevent the spread of COVID-19 infections in Europe, where the number of cases of the highly transmissible BA.2 subvariant is rapidly increasing and where public health safety measures have been relaxed in many countries. This broad recommendation for Evusheld will allow health authorities in the EU to identify priority, high-risk populations needing additional protection such as people with cancer, transplant patients, or anyone taking immunosuppressive me...