AstraZeneca seeks emergency approval for Covid antibody drug
AstraZeneca is seeking approval for a new Covid-19 treatment intended to help people who respond poorly to vaccines, the Anglo-Swedish drugs firm said on Tuesday.
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AstraZeneca said that Phase III trials of the antibody therapy, known as AZD7442, had shown a 77% reduction in risk of developing symptomatic Covid-19 compared to a placebo. The treatment is for people who do not respond well to vaccines because of weakened immune systems.
AstraZeneca has therefore applied to the US Food and Drug Administration for Emergency Use Authorisation. If granted, it would be the first long-acting antibody to receive approval for preventing Covid-19.
Mene Pangalos, executive vice president of biopharmaceuticals R&D at AstraZeneca, said: "Vulnerable populations such as the immunocompromised often aren’t able to mount a protective response following vaccination, and continue to be at risk of developing Covid-19. With this first global regulatory filing, we are one step closer to providing an additional option to help protect against Covid-19 alongside vaccines."
The firm added that it was in discussions about the supply of AZD7442 with the US government and other governments around the world.
As at 1215 BST, AstraZeneca’s London-listed shares were largely flat at 8,871p.
AstraZeneca’s widely-used Covid-19 vaccine, which it developed in conjunction with Oxford University, has yet to receive regulatory approval for use in the US.