The Medicines & Healthcare products Regulatory Agency (MHRA) has authorised AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) – the first antibody combination for pre-exposure prophylaxis against COVID-19 licensed in the UK.
The medicine is for use in adults not currently infected with COVID-19 and unlikely to mount an adequate response to COVID-19 vaccination, including those for whom vaccination is not recommended.
Around 500,000 in the UK are immunocompromised. The medicine presents significant benefits for this population, nearly 40% of whom mount a low or undetectable immune response after vaccination. Approximately 11% of the immunocompromised or immunosuppressed fail to generate any antibodies following vaccination.
The approval is particularly significant in the face of waning restrictions, which present significant threats to the health of many immunocompromised people in the UK.
The immunocompromised population includes those with blood cancers, those taking immunosuppressive drugs or those with conditions such as multiple sclerosis and rheumatoid arthritis.
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.”
The primary data from the ongoing phase 3 trial – which met its primary endpoint – showed a statistically significant reduction risk of developing symptomatic COVID-19 compared to placebo. There were no hospitalisations or deaths in the treatment arm.
“This announcement is really good news,” commented Hugh Montgomery, Professor of Intensive Care Medicine at University College London. “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,” he added.
