AstraZeneca PLC (LSE:AZN)’s preventative treatment for COVID-19 has been approved by the UK medical regulator, as an alternative for people for whom vaccines are not effective.
The new medicine, Evusheld, is a combination of two long-acting human monoclonal antibodies, tixagevimab and cilgavimab, has been authorised for COVID-19 prevention by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
The drug, which works by prevents the virus from attaching to and entering human cells, has been authorised to be used “before being exposed to the risk of COVID-19 infection in order to prevent disease”.
“Evusheld is a ‘pre-exposure prophylaxis’ treatment, meaning it is taken to prevent COVID-19 before the risk of acquiring infection,” said MHRA chief executive Dr June Raine.
“While the COVID-19 vaccines continue to be the first-line defence against COVID-19, we know that some people may not respond adequately to these vaccines and for a small number of individuals COVID-19 vaccines may not be recommended for other reasons, such as a previous allergic reaction to one of the vaccine ingredients.
“For these people, Evusheld could provide effective protection against COVID-19.”
The drug is not designed to be given to people who are currently infected with COVID or who has been in known close contact with someone who is infected with the virus.
Evusheld was given the green light after meeting regulatory standards for safety, quality and effectiveness, and was endorsed by the Commission on Human Medicines, after clinical trials in adults showed it reduced the risk of developing symptomatic COVID-19 by 77%, with protection from the virus continuing for at least 6 months following a single dose.
“There is not yet enough data to know how effective Evusheld is against Omicron or the duration of its effect against this variant, and the MHRA will work with the company to establish this,” the agency said in a statement.