Express Pharma

Evusheld recommended for approval in EU for prevention of COVID-19

Recommendation based on phase-III Provent trial showing a significant reduction in the risk of developing symptomatic COVID-19, with protection lasting at least six months

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AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for 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, a company statement notified.

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

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) 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 per cent reduction in the risk of developing symptomatic COVID-19 compared to placebo at the primary analysis and an 83 per cent 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, added the statement.

It informed that the recommended dose of Evusheld in Europe is 150mg of tixagevimab and 150mg of cilgavimab, administered as two separate sequential intramuscular (IM) injections.

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 per cent of COVID-19 infections in Europe. This study also showed Evusheld reduced viral burden and limited inflammation in the lungs (in-vivo) across all Omicron variants, mentioned the statement.

Evusheld is authorised for emergency use for pre-exposure prophylaxis of COVID-19 in the US and in six countries in Europe. It has also been granted conditional marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain for pre-exposure prophylaxis of COVID-19. It is the only long-acting antibody combination with positive phase-III data in the prevention and treatment of COVID-19.

AstraZeneca is progressing with filings around the globe for potential Emergency Use Authorisation (EUA) or marketing approval of Evusheld in both COVID-19 prophylaxis and treatment. The company anticipates that the European Commission will shortly complete its review of the CHMP positive opinion to determine whether to grant marketing authorisation, concluded the statement.

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