Business
Evusheld approved in EU for COVID-19 treatment
Evusheld approved in EU for COVID-19 treatment.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n 20 September 2022 07:00 GMT\n \n \n \n \n \n \n \n \n Evusheld\n \n \n long-acting antibody combination approved in the EU\n \n \n \n \n for the treatment of COVID-19\n \n \n \n \n \n \n \n \n \n Evusheld significantly reduced risk of severe COVID-19 or death\n \n \n \n \n in TACKLE Phase III treatment trial \n \n \n \n \n \n \n \n \n AstraZeneca's Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination, has been approved in the European Union (EU) for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with COVID‑19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID‑19.\n \n \n \n \n \n The approval by the European Commission was based on results from the TACKLE Phase III COVID-19 treatment trial which showed one intramuscular (IM) dose of Evusheldprovided clinically and statistically significant protection against progression to severe COVID-19 or death from any cause compared to placebo. Evusheld treatment earlier in the disease course led to more favourable outcomes. TACKLE was conducted in non-hospitalised adults with mild-to-moderate COVID-19 who were symptomatic for seven days or less.\n 90% of trial participants were at high risk of progression to severe COVID-19 due to co-morbidities or age.\n \n \n \n \n \n \n Evusheld\n \n was generally well tolerated in the trial.1\n \n \n \n \n \n Michel Goldman, M.D., Ph.D., Professor, Institute for Interdisciplinary Innovation in Healthcare, Université Libre de Bruxelles, and former Executive Director of the European Innovative Medicines Initiative, said: \"Many people, including those who are immunocompromised, older adults and those with underlying health conditions, are at high risk of severe disease, hospitalisation and death if they become infected. Evusheld, delivered in a convenient intramuscular formulation, is now a much-needed new COVID-19 treatment option for these vulnerable populations.\"\n \n \n \n \n \n Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said: \"COVID-19 remains an ongoing health concern for millions of Europeans and around the world, especially for those who may not be well-protected against the virus from vaccination. With this app...