AstraZeneca PLC has said its long-acting antibody combination Evusheld (tixagevimab and cilgavimab, formerly AZD7442) has been approved in the EU for the treatment of COVID-19.
The approval by the European Commission covers people over the age of 12 years who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID‑19, the pharmaceuticals group said.
The European Commission’s approval was based on results from the TACKLE phase III treatment trial which showed that Evusheld significantly reduced the risk of severe COVID-19 or death.
The recommended dose of Evusheld for treatment in Europe is 300mg of tixagevimab and 300mg of cilgavimab, administered as two separate, sequential IM injections, AstraZeneca (NASDAQ:AZN) noted.
"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," commented Dr Michel Goldman, professor at the Institute for Interdisciplinary Innovation in Healthcare, Université Libre de Bruxelles, and former executive director of the European Innovative Medicines Initiative in a statement.
Iskra Reic, executive vice president of vaccines and immune therapies at AstraZeneca, added: "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 approval, Evusheld is now the only long-acting antibody combination available for both prevention and treatment of COVID-19 in Europe, allowing us to protect even more people from this devastating disease."