AstraZeneca asks for emergency use authorization in US for COVID-19 preventive treatment
AstraZeneca said Tuesday that it has submitted a request for emergency use authorization of an antibody drug designed to help prevent symptomatic COVID-19.
The antibody therapy, called AZD7442, provides “statistically significant reduction” in the risk of developing COVID-19 and could provide another protective measure for vulnerable populations, including the immunocompromised, against the deadly disease, the company said in a statement
In its application to the Food and Drug Administration (FDA), AstraZeneca cited data from a trial showing the drug was 77 percent effective at thwarting symptomatic COVID-19. More than three-quarters of the tested population were immunocompromised or had other comorbidities associated with serious illness.
If FDA grants emergency use authorization for the drug, it will be the first long-acting antibody cocktail to receive such approval for COVID-19 prevention, the company said.
Mene Pangalos, AstraZeneca’s head of biopharmaceuticals research, said the antibody combination will help people who do not have a fully immune response to COVID-19 vaccines and need more to adequately prevent infections.
“With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines,” Pangalos said in the release.
The drugmaker added that discussions over AZD7442 supply agreements are “ongoing” with the U.S. and other governments worldwide.
The U.S. previously ordered 700,000 doses of the antibody cocktail.
Research on how AZD7442 treats against confirmed COVID-19 is expected “later this year,” Pangalos said.
The request to regulators comes as scientists have been testing different antibody cocktails to assist in averting COVID-19 infections, including among the immunocompromised such as cancer patients.
The FDA already issued an emergency use authorization in August for immunocompromised Pfizer and Moderna vaccine recipients to receive a third dose to boost their protection.
The U.S.’s potential authorization of AstraZeneca’s antibody cocktail would give the drugmaker an edge as others are developing and testing antibody treatments and preventions.
It would also come as the U.S. has yet to authorize the AstraZeneca COVID-19 vaccine. The drugmaker said in July it plans to seek approval from the FDA by the second half of 2021.
Updated at 8:43 a.m.