The drugmaker AstraZeneca, one of the first to develop a coronavirus vaccine, is requesting that the FDA approve an preventative antibody COVID-19 treatment for emergency use.
Approval would mean that the drug will be prioritized for people with compromised immune systems who don’t get enough protection from the virus through vaccines. The Anglo-Swedish company said Tuesday that the treatment, AZD&442, would be the first long-acting antibody combination to get emergency authorization for preventative purposes.
“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,” Mene Pangalos, AstraZeneca’s executive vice president for pharmaceutical research, said in a statement. “With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines.”
For more reporting from the Associated Press, see below.
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Antibody Treatment AstraZeneca
The drugmaker AstraZeneca, one of the first to develop a coronavirus vaccine, is requesting that the FDA approve an preventative antibody COVID-19 treatment for emergency use. Above, corporate logos are seen outside the Macclesfield factory of AstraZeneca on May 15, 2006, in Macclesfield, England. Christopher Furlong/Getty Images
The FDA has authorized three other antibody drugs already, including two that can be given after a possible COVID-19 exposure to head off symptoms. AstraZeneca’s drug would instead be given as a preventive measure in people who have increased vulnerability to the virus.
The FDA has stressed that antibody drugs are not a substitute for vaccination, which is the most effective, long-lasting form of virus protection. Antibody drugs also are expensive to produce and require an IV or injection and health care workers to administer.
Late-stage human trials showed that AstraZeneca’s antibody drug reduced the risk of developing symptomatic COVID-19 by 77 percent. More than three-quarters of the participants had suppressed immune systems and other conditions that made them more susceptible to severe disease.
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The drugs are laboratory-made versions of virus-blocking antibodies that help fight off infections. The treatments help the patient by supplying concentrated doses of one or two antibodies.
U.S. demand for the treatments soared over the summer, particularly in states like Florida, Louisiana and Texas, where unvaccinated patients threatened to overwhelm hospitals.
The main antibody treatments being used in the U.S. are from Regeneron and Eli Lilly & Co. The U.S. government has purchased bulk quantities of both drugs and oversees their distribution to the states.
AstraZeneca said it is in purchase talks with the U.S. and other governments around the world