AstraZeneca Seeks FDA Authorization Of Antibody Treatment That Reduces COVID Risk By 77%

AstraZeneca announced on Tuesday that it is seeking Emergency Use Authorization (EUA) for its long-acting COVID-19 antibody treatment that has reduced the risk of symptomatic cases of the virus by 77%.

If AstraZeneca’s submitted request to the Food and Drug Administration is authorized, those at high risk of COVID-19 would be able to use this treatment in conjunction with the vaccines. This would also mark the first preventive coronavirus treatment to be available in the U.S.

The drug would be delivered as an injection into the muscle like existing vaccines. What makes it different from vaccines is that instead of two separate injections at different points, this would be two shots at the same time, an AstraZeneca spokeswoman told the Wall Street Journal.

The British-Swedish multinational pharmaceutical trial tested the treatment mostly on participants who had at least one other medical condition that put them at higher risk of COVID complications or whose condition made the COVID vaccine less effective.

“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.

AstraZeneca’s vaccine has been authorized in multiple countries around the world, including Australia, Brazil, France, Germany, India, the U.K. and others.

The U.S. has yet to authorize the AstraZeneca vaccine and the request for FDA authorization for its antibody treatment could mean that the company could have at least one form of COVID-19 treatment circulating in the country.

AstraZeneca’s move also comes a few days after German pharmaceutical company Merck announced its plan to seek emergency authorization for its oral antiviral treatment for COVID-19.