AstraZeneca announces Evusheld long-acting antibody combination approved in the EU for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population
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.
The approval by the European Commission was based on results from the Evusheld clinical development programme, including 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. Evusheld was generally well-tolerated in the trial.
James Teague, Country President, AstraZeneca (Thailand) Ltd., said “As Thailand transitions from a pandemic to an endemic stage, we are committed to leave no patient behind. Evusheld is an option to provide additional protection to immunocompromised people, particularly the 607 population who are most vulnerable to the virus. They benefit from the pre-exposure prophylaxis with Evusheld.This EMA approval is really good news, and we are doing our best to make it available in Thailand soon.”
Evusheld is authorised for emergency use for pre-exposure prophylaxis of COVID-19 in the US and has been granted conditional marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain for pre-exposure prophylaxis of COVID-19. Additionally, there are a number of countries across Europe that have agreements in place to provide Evusheld.
