The EMA recommendation is based on the Phase 3 PROVENT trial, in which Evusheld significantly reduced the risk of developing symptomatic Covid-19
EU regulator recommends approval of Evusheld. (Credit: pearson0612 from Pixabay)
AstraZeneca announced that its antiviral candidate Evusheld (tixagevimab co-packaged with cilgavimab) has been recommended for regulatory approval in the European Union (EU).
European Medicines Agency (EMA)’s human medicines committee (CHMP) has granted a positive opinion on the marketing authorisation for Evusheld.
Evusheld is a combination of human monoclonal antibodies, tixagevimab and cilgavimab targeted against the surface spike protein of SARS-CoV-2 used to prevent Covid-19.
The long-acting antibody combination was indicated for pre-exposure prophylaxis (prevention) of Covid-19 in adults and adolescents aged 12 years and above.
EU regulator recommended Evusheld at a dosage of 150mg tixagevimab and 150mg cilgavimab in Europe, given as two separate sequential intramuscular injections.
AstraZeneca said that people who are not adequately protected by Covid-19 vaccination may benefit from the pre-exposure prophylaxis with Evusheld.
AstraZeneca biopharmaceuticals R&D executive vice president Mene Pangalos said: “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.”
The CHMP’s positive opinion was based on the review of Evusheld data, including results from the PROVENT Phase 3 pre-exposure prophylaxis trial.
In the Phase 3 study, Evusheld showed a 77% reduction in the risk of developing symptomatic Covid-19 compared to placebo, at the primary analysis.
Also, the treatment was generally well-tolerated and showed an 83% reduction of the risk at a six-month median analysis, with protection from the virus sustained for at least six months.
AstraZeneca said that the European Commission (EC) is most likely to complete the review of CHMP’s positive opinion, and decide on granting marketing authorisation soon.
Also, the company intends to file regulatory submissions with the agencies worldwide, for potential approval of Evusheld in both Covid-19 prophylaxis and treatment.
Earlier this month, UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved the therapy, to prevent Covid-19 in people with poor immune responses.