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.
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.
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.