AstraZeneca’s Evusheld, a long-acting antibody combination, has been granted marketing authorization 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.
“The EU approval represents an important milestone in our efforts to help prevent COVID-19, and we will continue to work with governments across Europe to make Evusheldavailable as quickly as possible. Evusheld has the potential to provide long-lasting protection against COVID-19 for a broad population of individuals, including those who aren’t adequately protected by a COVID-19 vaccine, as well as those at increased risk of exposure,” says Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca.
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.
People who are not adequately protected by a COVID-19 vaccine may particularly benefit from pre-exposure prophylaxis with Evusheld. This population includes about three million people in the EU who are immunocompromised such as people with cancer or transplant patients or anyone taking immunosuppressive medicines. People at increased risk of exposure to the SARS-CoV-2 virus could also benefit from protection with Evusheld.
Evusheld is the only long-acting antibody combination with positive Phase III data in the prevention and treatment of COVID-19.2,15 AstraZeneca is progressing with filings around the globe for potential emergency use authorisation or marketing approval of Evusheld in both COVID-19 prophylaxis and treatment.