5th Oct 2021 10:03
(Alliance News) - AstraZeneca PLC has submitted an emergency use authorisation request to the US Food & Drug Administration for its treatment for prophylaxis linked to Covid-19, the drug maker said Tuesday.
The AZD7442 drug will be the first long-acting antibody to receive an EUA for Covid-19 prevention if the FDA approval is granted.
Trials have previously shown the drug demonstrates a statistically "significant reduction in the risk of developing symptomatic Covid-19" compared to placebo. AZD7442 has the potential to provide protection for those not expected to mount an adequate immune response following vaccination, Astra noted.
"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," commented Mene Pangalos, executive vice president at Astra's BioPharmaceuticals Research & Development unit.
"With this first global regulatory filing, we are one step closer to providing an additional option to help protect against Covid-19 alongside vaccines."
Discussions regarding supply agreements for AZD7442 are ongoing with the US government as well as other governments around the world, Astra said.
Shares in the FTSE 100 constituent were trading up 0.5% at 8,869.00 pence each in London on Tuesday morning.
By Will Paige; [email protected]
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