AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) is authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) and is the first antibody combination for pre-exposure prophylaxis (PrEP) against COVID-19 licensed in Great Britain.
Tixagevimab co-packaged with cilgavimab, formerly known as AZD7442, is a combination of two monoclonal antibodies given as separate sequential intramuscular (IM) injections.
The use of this medicine is for adults who are not currently infected with (or know exposure to) the COVID-19 virus and are unlikely to mount an adequate response to COVID-19 vaccination – including those for whom vaccination is not recommended, AstraZeneca explained in its press release.
About 500,000 people in the UK are immunocompromised and may benefit from this medicine for pre-exposure prophylaxis of COVID-19. Nearly 40% of people with immunocompromised or immunosuppressed conditions mount a low or undetectable immune response after vaccination and approximately 11% fail to generate any antibodies. This includes people with blood cancers, those taking immunosuppressive drugs after an organ transplant or for conditions including multiple sclerosis and rheumatoid arthritis, the company said.
The primary data from the ongoing PROVENT Phase III trial (which met its primary endpoint) showed a statistically significant reduction in the risk of developing symptomatic COVID-19 with AZD7442 compared to placebo. The trial has shown protection from the virus continuing for at least six months. The antibody was tolerated and follow-up is needed to establish the full duration of protection, the company said.
Tom Keith Roach, President, 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.”