(Trends Wide) — AstraZeneca is applying for emergency use authorization from the US Food and Drug Administration (FDA) for an antibody therapy to prevent symptomatic COVID-19, particularly among people who are not likely to develop an immune response from vaccination.
“Vulnerable populations such as the immunosuppressed are often unable to develop a protective response after vaccination and remain at risk of developing COVID-19,” said Mene Pangalos, executive vice president of biopharmaceutical R&D at AstraZeneca, 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.”
The company previously announced the results of a trial that showed antibody therapy, known as AZD7442, reduced the risk of developing symptomatic COVID-19 by 77% compared to a placebo. He noted that most of the trial participants had underlying conditions that could increase their risk of severe COVID-19 or reduce their immune response to a vaccine. The therapy was well tolerated, the company said.
AstraZeneca said AZD7442 supply agreements continue with the US government and others around the world. The company said it will share data on the use of the therapy for COVID-19 treatment later this year.
(Trends Wide) — AstraZeneca is applying for emergency use authorization from the US Food and Drug Administration (FDA) for an antibody therapy to prevent symptomatic COVID-19, particularly among people who are not likely to develop an immune response from vaccination.
“Vulnerable populations such as the immunosuppressed are often unable to develop a protective response after vaccination and remain at risk of developing COVID-19,” said Mene Pangalos, executive vice president of biopharmaceutical R&D at AstraZeneca, 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.”
The company previously announced the results of a trial that showed antibody therapy, known as AZD7442, reduced the risk of developing symptomatic COVID-19 by 77% compared to a placebo. He noted that most of the trial participants had underlying conditions that could increase their risk of severe COVID-19 or reduce their immune response to a vaccine. The therapy was well tolerated, the company said.
AstraZeneca said AZD7442 supply agreements continue with the US government and others around the world. The company said it will share data on the use of the therapy for COVID-19 treatment later this year.