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AstraZeneca said on Tuesday it had asked the Food and Drug Administration to grant emergency clearance for long-acting antibody therapy to prevent Covid-19 in people at high risk of contracting the disease. If licensed, it would become the first such preventative treatment to be available in the United States, the company said.
The company said in a statement that the treatment reduced the risk of symptomatic Covid-19 by 77% in a trial in which most participants had other medical conditions that put them at increased risk of serious illness or did not produce not enough antibodies after vaccination. .
He said the treatment could be used in conjunction with vaccines in people with weaker immune systems. Other antibody treatments used in the United States, including one developed by drug maker Regeneron, have primarily been used to treat people already infected with the coronavirus. The AstraZeneca treatment is designed to stay in the body much longer than the antibody treatments available for Covid, the company said.
“Vulnerable populations such as the immunocompromised are often not able to build a protective response after vaccination and continue to be at risk of developing Covid-19,” said Mene Pangalos, executive vice president of AstraZeneca, in a press release. “With this first global regulatory filing, we’re one step closer to yet another option to help protect against Covid-19 alongside vaccines.”
An FDA clearance would boost the fortunes of AstraZeneca, whose coronavirus vaccine, used in many countries, has not been authorized in the United States.
Antibody treatments have gained more attention in recent months as an alternative, albeit expensive, tool against Covid-19 in the United States, especially by some who have avoided vaccines. The Biden administration stressed that vaccinations are the best way to prevent the spread of the coronavirus, but urged state and local health officials to make antibody therapy – which the federal government covers at a cost per dose of ‘about $ 2,100 – more widely available.
AstraZeneca treatment is one of many treatments in a class of therapies called monoclonal antibodies, which introduce disease-fighting, lab-made proteins into a patient’s body, usually through an infusion.
Last month, a World Health Organization panel approved the use of Regeneron’s antibody therapy in patients at high risk of Covid-19, while the health agency urged the company and its partner, Swiss manufacturer Roche, to reduce the cost of therapy and make it more widely available.
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