AstraZeneca asks FDA to authorize COVID antibody treatment

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Drugmaker AstraZeneca, which is developing one of the first COVID-19 vaccines, has asked the US Food and Drug Administration to authorize the emergency use of a first-of-its-kind antibody treatment to prevent the disease.

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The treatment, known as AZD7442, will be the first long-acting antibody combination to receive emergency authorization for the prevention of COVID-19, the Anglo-Swedish company said on Tuesday. If authorized, the drug would potentially be limited to people with compromised immune systems who do not receive adequate protection from vaccination.

“First and foremost we want to protect vulnerable populations that have not been adequately protected by vaccines,” said Meneles Pangaloa, AstraZeneca’s head of research and development. “But ultimately it will be up to health officials to decide who they want to vaccinate.”

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Pangaloa said the company’s longer-acting formulation is designed to boost immunity for up to a year, compared to existing drugs, which provide a month or two of protection.

The FDA has authorized three other antibody drugs, including two that can be given after possible COVID-19 symptoms have gone away. Instead the drug AstraZeneca will be given as a preventive measure in people who are at increased vulnerability to the virus.

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The FDA has stressed that antibody drugs are not a substitute for vaccination, which is the most effective, long-lasting form of protection against the virus. Antibody drugs are also expensive to produce and require IV or injection and health care workers to administer them.

Late-stage human trials showed that AstraZeneca’s antibody drug reduced the risk of developing symptomatic COVID-19 by 77%. More than three-quarters of the participants had suppressed immune systems due to cancer, lupus and other conditions that made them more vulnerable to serious illness.

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

The drugs are laboratory-produced versions of virus-blocking antibodies that help fight infection. Treatments help the patient by supplying a concentrated dose of one or two antibodies.

US demand for the treatment soared over the summer, especially in states such as Florida, Louisiana and Texas, where unvaccinated patients threatened to overwhelm hospitals.

The main antibody treatments being used in the US are those from Regeneron and Eli Lilly & Co. The US government purchases both drugs in bulk and oversees their distribution in the states.

AstraZeneca said it is in procurement talks with the US and other governments around the world. If authorized, Pangalos said the company is able to produce dosage amounts in the “low millions.”

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Peron reported from Washington, DC

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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.

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