The Committee for Medicinal Products for Human Use (CHMP) of the EMA recommended granting marketing authorisation for Evusheld, developed by AstraZeneca AB, for the prevention of COVID-19 disease in adults and adolescents aged 12 years and older and weighing at least 40kg prior to possible exposure to SARS-CoV-2 virus.
Evusheld consists of the active substances tixagevimab and cilgavimab, two monoclonal antibodies designed to bind to the spike protein of the SARS-CoV-2 virus (the virus that causes COVID-19 disease) at two different sites. When Evusheld's antibodies attach to the spike protein, the virus cannot enter cells to replicate and cannot cause COVID-19 disease.
To reach its conclusion, the CHMP evaluated data from one study in more than 5.000 people, which showed that Evusheld, given as two injections of 150mg tixagevimab and 150mg cilgavimab, reduced the risk of COVID-19 infection by 77%, with the duration of protection against the virus estimated to be at least six months. In the study, adults who had never contracted COVID-19 disease and had not received a COVID-19 vaccine or other preventive therapy received Evusheld or placebo (placebo injection). Of the people who received Evusheld, 0.2% (8 of 3,441) had laboratory-confirmed COVID-19 disease infection in the first six months after treatment, compared with 1.0% (17 of 1.731) of those receiving placebo.
The safety profile of Evusheld was favourable and adverse events were generally mild, with a small number of subjects reporting injection site reactions or hypersensitivity. The CHMP concluded that the benefits of the drug outweigh the risks for its authorised use and will now send its opinion to the European Commission for a rapid decision with effect in all EU Member States.
The study data were collected before the emergence of the Omicron variant which currently causes most COVID-19 disease infections worldwide. Laboratory studies show that the Omicron BA.1 variant may be less sensitive to tixagevimab and cilgavimab at doses of 150mg than the Omicron BA.2 variant. The EMA will study data in the coming weeks to assess whether an alternative dosing regimen might be appropriate for the prevention of COVID-19 disease resulting from emerging variants.
Where to find more information
The product information for Evusheld contains information for healthcare professionals, an instruction leaflet for the public and details of the licensing conditions for the medicine.
The assessment report with details of the EMA's evaluation of Evusheld and the full risk management plan will be published shortly. The clinical trial data submitted by the company as part of the marketing authorisation application will be published on the Agency's clinical data website in due course.
Further information will also be available in a plain language review of the medicine, including a description of the benefits and risks of the medicine and why the EMA recommended its authorisation in the EU.
Evaluation of Evusheld
In evaluating Evusheld, the CHMP received the support of the EMA's safety committee, PRAC, which evaluated Evusheld's risk management plan, as well as the COVID-19 EMA Pandemic Task Force (COVID-ETF), a group bringing together experts from across the European medicines regulatory network to facilitate rapid and coordinated regulatory action on COVID-19 medicines and vaccines.
Evusheld was evaluated as part of "OPEN", an initiative launched in December 2020 to enhance international collaboration when evaluating, at EU level, vaccines and treatments against COVID-19 disease. More information is available on the EMA's website on dairy governance during the COVID-19 pandemic.
(AF)
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