ANOTHER FDA REQUEST: ASTRAZENECA’S COVID-19 PREVENTATIVE TREATMENT
AstraZeneca also submitted a request for emergency use authorization on Tuesday — for 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.
Significance: If the 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.