AstraZeneca Pursues Emergency Authorization for COVID-19 Antibody Combo

AstraZeneca has filed for an FDA Emergency Use Authorization (EUA) for its long-acting antibody (LAAB) combination, AZD7442, as a preventive for symptomatic COVID-19.

The application was supported by positive phase 3 data showing a 77 percent reduction in risk of developing symptomatic COVID-19, and the treatment, if cleared, would become the first LAAB product to receive an EUA for the prevention of COVID-19.

The Anglo-Swedish drugmaker, which hopes to launch AZD7442 by year’s end, said the long-acting combination could offer protection for those unable to mount a proper immune response after receiving a COVID-19 vaccine. That includes its own jab co-developed with Oxford-University. While authorized in the UK and EU, that shot has yet to receive any approval in the U.S.

Produced by combining two LAABs, tixagevimab and cilgavimab, gathered from the B-cells of convalescent patients who contracted SARS-CoV-2, AZD7442 works by attaching to sites on the virus’ spike protein and contains an added half-life extension to prolong its effectiveness.