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AstraZeneca, the drugmaker who developed one of the first Covid-19 vaccines, has asked the Food and Drug Administration to allow emergency use of a one-of-a-kind antibody treatment to prevent the disease .
The Anglo-Swedish company said on Tuesday that the treatment, known as AZD7442, would be the first long-acting antibody combination to receive emergency clearance for the prevention of COVID-19. If allowed, the drug would likely be restricted to people with weakened immune systems who do not have sufficient protection against vaccination.
“Above all, we want to protect vulnerable populations who have not been sufficiently protected by the vaccine,” said Menelas Pangaloa, head of research and development at AstraZeneca. “But at the end of the day, it will be up to health authorities to determine who they choose to vaccinate. “
Pangaloa said the company’s long-acting formulation is designed to boost immunity for up to a year, compared to existing drugs that offer a month or two of protection.
The FDA has cleared three other antibody-based drugs, two of which can be given after possible exposure to Covid to prevent symptoms. Rather, the AstraZeneca drug would be given as a preventive measure to people with increased vulnerability to the virus.
The FDA has stressed that antibody-based drugs are not a substitute for vaccination, which is the most effective and long-lasting form of viral protection. Antibody drugs are also expensive to produce and require an intravenous or injection and health workers to be administered.
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Late-stage human trials have shown that AstraZeneca’s antibody drug reduced the risk of developing symptomatic COVID-19 by 77%. More than three-quarters of the participants had weakened immune systems due to cancer, lupus and other conditions that made them more susceptible to serious illness.
Pangalos said the company’s drug will provide “an additional option to help protect against COVID-19 alongside vaccines.” The company will also seek regulatory clearance in Europe and other parts of the world.
Medicines are laboratory-made versions of antibodies that block viruses that help fight infections. The treatments help the patient by providing concentrated doses of one or two antibodies.
U.S. demand for treatments has skyrocketed over the summer, especially in states like Florida, Louisiana and Texas, where unvaccinated patients have threatened to overwhelm hospitals.
The main antibody treatments used in the United States come from Regeneron and Eli Lilly & Co. The United States government has purchased significant 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. If licensed, Pangalos said the company is capable of producing dose amounts in the “millions” range.
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