The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorisation to AstraZeneca’s Evusheld (AZD7442) for pre-exposure prophylaxis (PrEP) against Covid-19.
Evusheld is a cocktail of two monoclonal long-acting antibodies, tixagevimab and cilgavimab.
AstraZeneca licensed the antibodies discovered by Vanderbilt University in June 2020.
The antibody combination acts by attaching to the SARS-CoV-2 virus’ spike protein. This approach hinders the entry of the virus into human cells.
According to the MHRA approval, Evusheld is indicated for usage in adults who are not presently infected with or exposed to Covid-19 and those who might not have sufficient response to the vaccine.
Tixagevimab and cilgavimab will be administered as separate sequential intramuscular (IM) doses.
According to initial results from an ongoing Phase III PROVENT trial, AZD7442 demonstrated to offer a statistically significant decline in the risk of symptomatic Covid-19 development versus placebo, meeting the primary endpoint.
Data also showed that the treatment offered protection from the virus that lasted for a minimum of six months and AZD7442 was demonstrated to be tolerated.
After analysing 5,172 subjects, it was found that the antibody combination showed a 77% and 0.8% relative risk reduction (RRR) and absolute risk reduction (ARR), respectively, in the occurrence of symptomatic disease versus placebo, with a median follow-up of 83 days.
AstraZeneca UK president Tom Keith Roach 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.”
In December last year, Evusheld obtained emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for Covid-19 pre-exposure prophylaxis.