AstraZeneca gets UK MHRA approval for Evusheld for Covid-19 prevention
AstraZeneca said that its antibody combination Evusheld (tixagevimab co-packaged with cilgavimab) has been authorized by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the prevention of Covid-19 in Britain.
Evusheld has been approved to be used in adults who are not presently infected with (or know exposure to) the Covid-19 virus and are not expected to mount an adequate response to Covid-19 vaccination, including people for whom vaccination is not recommended.
Tom Keith Roach — President of AstraZeneca UK said: “Evusheld fills an urgent gap in the UK’s fight against COVID-19, providing protection for people for whom vaccination may not be effective and who are often amongst the most clinically vulnerable in society. We hope to see this critical medicine made available to UK patients as quickly as possible, in line with other countries.”
Previously called AZD7442, Evusheld is a combination of the two monoclonal antibodies — tixagevimab (AZD8895) and cilgavimab (AZD1061), that are administered as separate sequential intramuscular (IM) injections. The monoclonal antibodies are derived from B-cells donated by convalescent patients after getting exposed to SARS-CoV-2 virus.
The MHRA approval for Evusheld has been driven by the primary data from the ongoing PROVENT phase 3 clinical trial, which met its primary endpoint. The late-stage trial delivered a statistically significant reduction in the risk of developing symptomatic Covid-19 with AZD7442, in comparison to placebo.
The PROVENT clinical trial has shown protection from the SARS-CoV-2 virus continuing for at least six months, said AstraZeneca.