AstraZeneca asks FDA to authorize COVID antibody treatment

London Oct 5 (BUS) : AstraZeneca, the pharmaceutical company that developed one of the first COVID-19 vaccines, has asked the US Food and Drug Administration for emergency use of its first-of-its-kind antibody treatment for prevention. the disease.

The Anglo-Swedish company said on Tuesday that the treatment, known as AZD7442, would be the first long-acting antibody group to receive emergency clearance to prevent COVID-19.

If licensed, the drug would likely be restricted to people with compromised immune systems who don’t get adequate protection from vaccination, according to the Associated Press.

“First and foremost we want to protect vulnerable populations who have not been adequately protected by the vaccine,” said Minelas Bangaloa, head of research and development at AstraZeneca. “But in the end, it will be up to the health authorities to decide who to opt for immunization.”

Bangalwa said the company’s long-acting formula is designed to boost immunity for up to one year, compared to current drugs that provide a month or two of protection.

The FDA has allowed three more antibody drugs, including two that can be given after potential exposure to COVID-19, to avoid symptoms. Instead, AstraZeneca will be given as a preventative measure to people who have had increased exposure to the virus.

The US Food and Drug Administration (FDA) has confirmed that antibody drugs are not a substitute for vaccination, which is the most effective and long-lasting form of virus protection. The production of antibody drugs is also expensive and requires intravenous injections or healthcare workers to administer.

Late-stage human trials have shown that the antagonist AstraZeneca reduces the risk of developing COVID-19 symptoms by 77%. More than three-quarters of the participants had a weakened immune system due to cancer, lupus and other conditions that put them at higher risk of serious illness.

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Pangalos said the company’s drug will provide “an additional option to help protect against COVID-19 besides vaccinations.” The company will also seek regulatory permission in Europe and other regions around the world.

The drugs are lab-made versions of virus-blocking antibodies that help fight infection. Treatments help the patient by providing concentrated doses of one or two antibodies.

The main antibody therapies used in the United States are from Regeneron, Eli Lilly & Co. The US government has purchased large quantities of both drugs and oversees their distribution in the states.

AstraZeneca said it is in purchase talks with the United States and other governments around the world. Pangalos said the company is able to produce dose quantities in the “few million” if authorized.


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