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Evusheld approved in the EU for COVID-19
Evusheld approved in the EU for COVID-19.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 1552G\n AstraZeneca PLC\n 28 March 2022\n \n \n \n \n 28 March 2022 07:00 BST\n \n \n \n \n \n \n Evusheld\n \n \n long-acting antibody combination approved in the EU for\n \n \n \n pre-exposure prophylaxis (prevention) of COVID-19 in a broad population\n \n \n \n \n \n \n Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months\n \n \n \n \n \n Evusheld retains neutralising activity against the Omicron BA.2 subvariant, \n \n \n now the dominant strain in Europe\n \n \n \n \n \n AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted 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 The approval by the European Commission was based on results from the Evusheld clinical development programme, including \n data 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 lasting at least six months.1-3Evusheld was generally well-tolerated in the trial.1-3\n \n \n \n \n \n Christoph D. Spinner, MD, Consulting Physician Infectious Diseases and Pandemic Officer at the University Hospital Rechts der Isar and adjunct teaching professor at the Technical University of Munich, Munich, Germany, said: \"Increasing COVID-19 cases, driven by the highly-transmissible BA.2 subvariant, and withdrawal of several pandemic public health measures make it important to protect vulnerable populations, such as the immunocompromised, from SARS-CoV-2 infection. The authorisation of Evusheld for a broad population will allow health authorities in the EU to identify the populations who are most at-risk and need additional protection.\" \n \n \n \n \n \n Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: \"The EU approval represents an important milestone in our efforts to help prevent COVID-19, and we will continue to work with gov...