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www.fdanews.com/articles/204087-astrazeneca-says-its-antibody-therapy-prevents-symptomatic-covid-19

AstraZeneca Says Its Antibody Therapy Prevents Symptomatic COVID-19

August 23, 2021

AstraZeneca said its monoclonal antibody treatment AZD7442 was shown to reduce the risk of developing COVID-19 symptoms by 77 percent vs. placebo in a phase 3 study — and it plans to use the findings to support global Emergency Use Authorizations and conditional approvals.

AstraZeneca anticipates that the antibody will be used as an alternative to vaccines for those who refuse to get inoculation and for individuals who don’t receive effective protection from vaccines.

There were no cases of severe disease or COVID-19-related death in the study arm receiving AZD7442, but there were two deaths and three cases of severe COVID-19 in the placebo cohort, the company said. The global late-stage trial contained 25 cases of symptomatic COVID-19 at the time of the primary analysis, with the study enrolling almost 5,200 total participants.

“We are very encouraged by these efficacy and safety data in high-risk people, showing our long-acting antibody combination has the potential to protect from symptomatic and severe disease, alongside vaccines,” said Mene Pangalos, AstraZeneca’s executive vice president.

AZD7442 is formed by combining two long-acting antibodies, tixagevimab and cilgavimab, produced from the B-cells of convalescent patients who have contracted the coronavirus. The drug works by binding to the SARS-CoV-2 spike protein and mimicking the body’s natural disease-fighting antibodies.

AstraZeneca said full late-stage trial results will be submitted to peer-reviewed publications and will be presented at an upcoming medical conference. ― Jason Scott