Yahoo Finance AstraZeneca seeks emergency US approval for COVID antibody drug
AstraZeneca (AZN.L) has requested emergency authorisation from the US Food and Drug Administration (FDA) for its COVID-19 drug, which could protect those who may not develop a robust immune response to vaccines.
The antibody therapy, called AZD7442, is the first long-acting antibody (LAAB) “with Phase III data demonstrating a statistically significant reduction in the risk of developing symptomatic COVID-19 compared to placebo,” the drug maker said in a statement.
While a vaccine helps a recipient’s immune system build antibodies on its own against a virus, antibody treatments use lab-made antibodies that can stay in a person's body for months and protect them against infection.
If granted, AZD7442 would be the first LAAB to receive an emergency use authorisation for COVID-19 prevention.
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“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,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D at AstraZeneca.
“With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines. We look forward to sharing AZD7442 data for the treatment of COVID-19 later this year.”
In August 2021, results from a trial showed AZD7442 reduced the risk of developing symptomatic COVID-19 by 77%.
AZD7442 is being studied in a clinical trial programme for both prevention and treatment of COVID-19 in over 9,000 participants.
It was discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020. it is being developed with support from the US government, including federal funds from the Department of Health and Human Services.
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COVID-19 vaccines, including the one developed by AstraZeneca, have had significant success in combating the disease but so far there is no treatment to help reduce symptoms in patients who already have the virus.
Merck & Co (MRK) recently said it will pursue emergency use authorisation “as soon as possible” for its COVID-19 oral antiviral pill, following data showing an approximately 50% reduction in the risk of hospitalisation or death in patients 29 days after treatment.
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