AstraZeneca Seeks EUA for COVID-19 Preventive Antibody Therapy
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.
And the AstraZeneca development occurs as Merck and Ridgeback Biotherapeutics have emerged as the frontrunner for seeking authorization for their COVID-19 oral antiviral, expected to occur this month. But unlike the Merck/Ridgeback pill, AZD7442 is instead administered via intramuscular injection, each dose given as two shots in the gluteal region within eight days of exposure (DID, Oct. 4).
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. ― Jason Scott