FDA的独立研究显示，长效抗体组合Evusheld对Omicron变体保持了中和活性

Since the emergence of the Omicron variant, the world has once again been plunged into the "whirlpool" of a pandemic. This mutant strain appears to be more ferocious than the previous Delta variant. It spreads extremely fast. The number of new cases in the United States can be said to be doubling every three days. In the past two weeks, new cases in the United States have increased by 40%, deaths have increased by 34%, and hospitalizations have increased by 21%. Nonetheless, Evusheld's data provide a sedative.

In the study, Evusheld's inhibitory concentration 50 (IC50), a measure of antibody neutralizing potency, in two confirmatory trials was 171 ng/ml and 277 ng/ml, respectively, which was within the range of neutralizing titers seen in patients with previous COVID-19 infection. The IC50 of Evusheld against the original strain of SARS-CoV-2 is approximately 1.3 ng/ml and 1.5 ng/ml respectively.

This early data, generated by pseudoviral testing of Evusheld (tixagevimab and cilgavvimab combination) against the full range of spikes of Omicron variants, provides further evidence that Evusheld maintains activity against all variants of concern to date.

The study was conducted independently by researchers at the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research and was supported by U.S. government research funds.

Mene, Executive Vice President, Biopharmaceuticals R&D, AstraZeneca "This study shows that Evusheld maintains neutralizing activity against Omicron variants," Pangalos said. "By combining two potent antibodies with distinct and complementary activities against Omicron variants, Evusheld is designed to protect against new mutations in SARS-CoV-2." Potential drug resistance developed by the body. Evusheld is the first long-acting antibody to receive emergency use authorization in the United States for COVID-19 pre-exposure prophylaxis. We are working with the FDA to apply for use of Evusheld to treat COVID-19."

During the Evusheld clinical trial, the Omicron variant was not yet prevalent. AstraZeneca is continuing to collect additional data to better understand the implications of this observation in clinical practice. The company is working with third-party labs to conduct additional analyzes of Evusheld against Omicron variants, with results expected soon.

In December 2021, Evusheld received Emergency Use Authorization (EUA) in the United States for COVID-19 pre-exposure prophylaxis. The applicable population mainly includes groups with moderate to severe immune impairment due to medical conditions or immunosuppressive drugs and the inability to adequately respond to the COVID-19 vaccine, as well as individuals for whom vaccination against COVID-19 is not recommended. The first batch of Evusheld is expected to be available within days.

Additionally, Evusheld's Phase 3 TACKLE outpatient treatment trial showed that Evusheld reduced the risk of progression to severe COVID-19 or death (from any cause) by 50% compared with placebo in patients with mild to moderate non-hospitalized COVID-19 (symptom onset within 7 days)

References:

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/evusheld-long-acting-antibody-combination-retains-neutralising-activity-against-omicron-variant-in-independent-fda-study.html