AstraZeneca PLC (LSE:AZN) has received EU marketing authorisation for its Evusheld antibody combination for the prevention of COVID-19 in a broad population.
The Cambridge, England-based firm said the drug was approved for the prevention of COVID-19 in people aged 12 years and older who weigh at least 40 kilograms.
Phase 3 study results have shown that Evusheld (a combination of tixagevimab and cilgavimab) lowered the risk of developing symptomatic COVID-19 by 77% initially compared with placebo, with protection lasting for at least six months.
"Increasing COVID-19 cases, driven by the highly-transmissible BA.2 subvariant, and withdrawal of several pandemic public health measures make it important to protect vulnerable populations, such as the immunocompromised, from infection," said Christoph Spinner, consulting physician at the University Hospital Rechts der Isar.
As a result of the authorisation of Evusheld for a broad population, health authorities in the EU can identify those at risk and who need additional protection, Spinner said.
Preventative treatment with Evusheld may be particularly beneficial for people not adequately protected by a COVID-19 vaccine, AstraZeneca said, adding this included three million people in the EU with cancer, transplant patients, or anyone taking immunosuppressive medicines.
Evusheld is authorised for emergency use for the prevention of COVID-19 in the US, and has been granted conditional marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The company said there are a number of countries across Europe that have agreements in place to provide Evusheld.
Shares in AstraZeneca were up 0.56% at 9,898 pence on Monday morning in London.