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AstraZeneca’s Evusheld recommended for approval in the EU

AstraZeneca’s Evusheld, a long-acting antibody combination, has been recommended for marketing authorization in the 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.

People not adequately protected by a COVID-19 vaccine may particularly benefit from pre-exposure prophylaxis with Evusheld, states the company. This includes about three million people in the EU who are immunocompromised or being treated with immunosuppressive medicines.

“Today’s positive CHMP recommendation represents a significant step forward in our ongoing efforts to introduce additional, important preventative measures for people in Europe at higher risk of developing COVID-19. Evusheld has the potential to provide long-lasting protection to vulnerable populations such as the immunocompromised who can’t mount an adequate response to a COVID-19 vaccine, and we’ll continue to work with governments in Europe to make Evusheld available as quickly as possible,” says Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca.

The PROVENT Phase III trial

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on a review of Evusheld data, including results 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 continuing for at least six months. Evusheld was generally well-tolerated in the trial.

New data from Washington University School of Medicine

There is a growing body of evidence from multiple independent in vitro and in vivo (animal model) studies supporting the potential of Evusheld to protect against the BA.1, BA.1.1 and BA.2 Omicron SARS-CoV-2 subvariants in circulation around the world. New data from Washington University School of Medicine demonstrated Evusheld retained potent neutralising activity against the emerging and highly transmissible BA.2 subvariant, which is the dominant strain in many European countries and currently accounts for nearly 60% of COVID-19 infections in Europe.7,8 This study also showed Evusheld reduced viral burden and limited inflammation in the lungs (in vivo) across all Omicron variants.

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Evusheld is authorized for emergency use for pre-exposure prophylaxis of COVID-19 in the US and in six countries in Europe. Evusheld has also been granted conditional marketing authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain for pre-exposure prophylaxis of COVID-19.

AstraZeneca anticipates that the European Commission will shortly complete its review of the CHMP positive opinion to determine whether to grant marketing authorization.

AstraZeneca is progressing with filings around the globe for potential emergency use authorization or marketing approval of Evusheld in both COVID-19 prophylaxis and treatment.

Photo of Mene Pangalos: AstraZeneca