AstraZeneca (AZ) has announced that its antibody combination treatment Evusheld (tixagevimab co-packaged with cilgavimab) has been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).
It is the first antibody combination for pre-exposure prophylaxis (PrEP) against COVID-19 to be licensed in the UK.
The treatment is authorised for use in adults who are not currently infected with – or have had a known exposure to – the COVID-19 virus and are unlikely to have an adequate response to COVID-19 vaccination. This includes those for whom vaccination is not recommended.
In the UK, around 500,000 people are immunocompromised and could therefore potentially benefit from this treatment for pre-exposure prevention of COVID-19.
Nearly 40% of people with immunocompromised or immunosuppressed conditions have a low or undetectable immune response after vaccination, while an estimated 11% fail to generate any antibodies. This includes those patients diagnosed with blood cancers, those taking immunosuppressive drugs after an organ transplant, or for conditions including rheumatoid arthritis and multiple sclerosis.
The antibody combination treatment will be administered as separate sequential intramuscular injections.
The ongoing PROVENT phase 3 trial – which met its primary endpoint – demonstrated a statistically significant decrease in the risk of developing symptomatic COVID-19 with AZD7442, compared to placebo.
Additionally, the trial shows that people continue to be protected from the virus for at least six months. A follow-up is needed to establish the complete duration of protection.
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.”
Hugh Montgomery, Professor of Intensive Care Medicine at University College London, said: “This announcement is really good news. Sensible public health actions with vaccination are the mainstay of protection for most individuals in the UK.
“However, for a considerable number in society with existing health problems, protection against the virus through vaccination is limited. Availability of this antibody medicine now offers an increased likelihood of pre-exposure protection, and all from a single, effective immunisation that can last for months.”