CHMP recommends marketing authorisation for AZ’s Evusheld in the EU

AstraZeneca’s Evusheld, a long-acting antibody combination, has received a recommendation for marketing authorisation in the European Union (EU). The treatment – given as two intramuscular injections – is for the pre-exposure prevention of COVID-19, and can be given to adults and children aged 12 years and older.

The Committee for Medicinal Products for Human Use (CHMP) branch of the European Medicines Agency based its positive opinion on an evaluation of Evusheld data, which included results from the PROVENT phase 3 pre-exposure prevention trial.

The trial showed a 77% reduction in the risk of developing symptomatic COVID-19 compared to placebo. Additionally, it showed an 83% reduction at six months, with protection continuing for at least six months.

Those who are not protected by a COVID-19 vaccine – including around three million people living in the EU who are immunocompromised or being treated with immunosuppressive medicines – may benefit from pre-exposure prevention with Evusheld.

Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, said: “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.”

Hugh Montgomery, Professor of Intensive Care Medicine at University College London, UK and Evusheld investigator said: “Despite the success of vaccinations, we still need additional measures to prevent the spread of COVID-19 infections in Europe, where the number of cases of the highly transmissible BA.2 subvariant is rapidly increasing and where public health safety measures have been relaxed in many countries.

“This broad recommendation for Evusheld will allow health authorities in the EU to identify priority, high-risk populations needing additional protection such as people with cancer, transplant patients, or anyone taking immunosuppressive medicines, as well as those at increased risk of exposure.”

AZ has said it expects the European Commission will soon complete its review of the CHMP decision on whether to grant a marketing authorisation. Evusheld is authorised for emergency use for pre-exposure prevention of COVID-19 in the US and in six countries in Europe. The treatment has also been given a conditional marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.