WILMINGTON, Del.– AstraZeneca’s EVUSHELD (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination for the prevention of COVID-19, retains neutralization activity against the Omicron SARS-CoV-2 variant (B.1.1.529), according to new authentic ‘live’ virus neutralization data from both University College Oxford, UK and Washington University School of Medicine, St. Louis, US.
The findings were posted online on bioRxiv, a preprint server, here and here.
EVUSHELD’s Inhibitory Concentration 50 (IC50), a measure of neutralizing potency of an antibody, was 273 ng/ml and 147 ng/ml in the Oxford and Washington University studies, respectively.1,2 The levels are within the range of neutralizing antibody titers found in individuals who have been previously infected with and recovered naturally from COVID-19.3
The data were generated from laboratory testing using actual live virus isolated from individuals who contracted the Omicron variant of COVID-19, considered a ‘gold standard’ for antibody neutralization studies.4 EVUSHELD is one of only two antibody therapies authorized for use that showed neutralizing activity against Omicron and against all other variants of concern in these two studies.1,2
These findings are in line with pseudovirus neutralizing data from independent investigators at the US Food and Drug Administration (FDA) announced on December 16, 2021, and add to the growing body of preclinical evidence demonstrating that EVUSHELD retains activity against all tested SARS-CoV-2 variants of concern to date.5
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Consistent data across three independent studies now provide confidence that EVUSHELD, a combination of two highly potent antibodies, retains neutralizing activity against the Omicron variant at a level that will continue to provide benefit to patients. EVUSHELD is the only antibody therapy authorized for pre-exposure prophylaxis of COVID-19 in the US, and we’re excited that EVUSHELD is now available to help protect vulnerable populations, such as the immunocompromised, who are unable to mount an adequate response to vaccination and who remain at high-risk for COVID-19.”
By combining two particularly potent antibodies with different and complementary activities against the virus, EVUSHELD was designed to evade potential resistance with the emergence of new SARS-CoV-2 variants.
The Omicron variant was not in circulation during the EVUSHELD clinical trials. The Company is continuing to collect further data to better understand the implications of these data in clinical practice. Data from both studies will be submitted for publication in a peer-reviewed journal.
EVUSHELD received Emergency Use Authorization (EUA) in the US in December 2021 for the pre-exposure prophylaxis (prevention) of COVID-19 in people with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to COVID-19 vaccination, as well as those individuals for whom COVID-19 vaccination is not recommended.
About 2% of the global population is considered at increased risk of an inadequate response to a COVID-19 vaccine.6,7 Recent emerging evidence indicate that protecting vulnerable populations from getting COVID-19 could help prevent viral evolution that is an important factor in the emergence of variants.8
EVUSHELD is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of EVUSHELD under Section 564(b)(1) of the Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
