Early Data Show Evusheld Retains Neutralizing Activity Against Omicron

Early data from an independent study conducted by investigators at the Food and Drug Administration show that the long-acting antibody therapy Evusheld (tixagevimab co-packaged with cilgavimab) retains neutralizing activity against the SARS-CoV-2 Omicron variant (B.1.1.529).

The FDA recently issued an Emergency Use Authorization (EUA) for Evusheld for the pre-exposure prophylaxis of COVID-19 in certain individuals 12 years of age and older weighing at least 40kg. The first doses are expected to become available within days.

Results from 2 confirmatory tests show that the neutralizing potency of the antibody combination was within the range of neutralizing titers found in an individual previously infected with COVID-19. “This study shows Evusheld retains neutralization activity against the Omicron variant,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca. “By combining 2 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.”

Additional analyses will be conducted by AstraZeneca to evaluate Evusheld against Omicron as the variant had not been in circulation during the clinical trials.


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The Company also announced results from the phase 3 TACKLE trial (ClinicalTrials.gov Identifier: NCT04723394), which showed that treatment with Evusheld reduced the risk of developing severe COVID-19 or death from any cause by 50% compared with placebo in nonhospitalized patients with mild to moderate COVID-19 who were symptomatic for 7 days or less. 

Reference

Evusheld long-acting antibody combination retains neutralizing activity against Omicron variant in independent FDA study. News release. AstraZeneca. Accessed December 16, 2021. https://www.astrazeneca.com/media-centre/press-releases/2021/evusheld-long-acting-antibody-combination-retains-neutralising-activity-against-omicron-variant-in-independent-fda-study.html

Source: Medical Bag https://www.medicalbag.com/home/news/early-data-show-evusheld-retains-neutralizing-activity-against-omicron/

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