AstraZeneca has secured the US Food and Drug Administration (FDA) emergency use authorisation (EUA) for its Evusheld (tixagevimab co-packaged with cilgavimab) to prevent Covid-19.
The drug is indicated for people aged 12 and above, who are immunocompromised, not responsive to Covid-19 vaccination, and those not eligible for Covid-19 vaccination.
It is not advised for people who are currently infected with SARS-CoV-2, or had known exposure to an infected person recently.
Previously called AZD7442, Evusheld is a combination of two long-acting monoclonal antibodies (LAABs) tixagevimab (AZD8895) and cilgavimab (AZD1061).
The antibodies were originally discovered by Vanderbilt University Medical Centre and were licensed to AstraZeneca in June last year.
Evusheld is the only antibody drug to receive FDA EUA for Covid-19 pre-exposure prophylaxis and the only Covid-19 antibody administered intramuscularly, said the company.
AstraZeneca biopharmaceuticals R&D executive vice president Mene Pangalos said: “With Evusheld, we now have the first antibody therapy authorised in the US to prevent Covid-19 symptoms before virus exposure.
“Evusheld neutralises all previous SARs-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant.
“We thank our clinical trial participants, the investigators, scientists, and government agencies and our colleagues at AstraZeneca who have all contributed to the development of Evusheld.”
The FDA EUA was supported by data from the ongoing Phase 3 PROVENT pre-exposure prevention trial, in 5,172 participants, who had not received a Covid-19 vaccine.
In the study, a single dose of Evusheld was administered as two separate successive intramuscular injections, one for each antibody.
The drug showed a significant reduction in the risk of developing symptomatic Covid-19.
The participants who received Evusheld experienced a 77% reduced risk of developing symptomatic Covid-19, in the primary analysis, and 83% at median analysis, compared to placebo.
In the additional analyses, the drug has retained its capability to reduce the Covid-19 risk for at least six months, and was well-tolerated in the clinical trials, said the firm.
PROVENT trial principal investigator professor Myron J Levin said: “Millions of people in the US and around the world remain at serious risk for Covid-19 because their immune systems do not generate a sufficient immune response, even after receiving all recommended doses of vaccine.
“I am excited to offer my patients Evusheld as an easily-administered new option that provides long-lasting protection that could help them return to their everyday lives.”
The US agency noted that pre-exposure prevention using Evusheld is not an alternative for vaccination for people who are eligible to receive a Covid-19 shot.
AstraZeneca has agreed to supply 700,000 doses of its Evusheld to the US government, which is planning to distribute the doses in the country free of cost.
