AstraZeneca seeking U.S. authorization for drug to prevent symptomatic COVID-19

AstraZeneca has submitted a request to U.S. regulators for an emergency use authorization for a drug that the company says prevents symptomatic COVID-19.

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The drug, an antibody combination called AZD7442 that is delivered as an injection, could offer an alternative to vaccinations in people whose immune systems are compromised, according to the pharmaceutical company.

“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, an executive vice president at AstraZeneca, 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.”

Results of trials by AstraZeneca showed AZD7442 had 77% efficacy in reducing risk of symptomatic COVID-19. In those trials, three-fourths of participants had a comorbidity, or a chronic disease or disorder that renders vaccines less effective. People with those comorbidities have a difficult time mounting a strong immune response to viruses.

The drug failed in trials for its original use, as a medication to treat acute COVID-19 symptoms and curb infections to keep people who had been exposed to the virus but not yet hospitalized with serious symptoms.

After the setback, AstraZeneca redirected the drug toward one that serves as an alternative to vaccines for people with weakened immune systems.

In addition to U.S. regulators, AstraZeneca is talking to regulators in the United Kingdom and Europe to gain authorization use for the drug, a monoclonal antibody, a company spokeswoman said Tuesday.

A monoclonal antibody is a protein produced in a laboratory that is given to people to help their immune system recognize and fight off disease.

The antibody treatment, which is given in two injections at the same time, is separate from AstraZeneca’s COVID-19 vaccine developed with researchers at the University of Oxford and used in many countries, but not the United States.

The antibodies were developed at Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, according to The Wall Street Journal.