AstraZeneca Seeks Approval for COVID Antibody Drug

masslive.com

AstraZeneca asked the Food and Drug Administration for an Emergency Use Authorization for a drug it says can significantly cut the risk of developing symptomatic COVID.

The European pharmaceutical company announced Tuesday that its “long-acting antibody” drug, or LAAB, had shown in trials it could reduce the risk of developing symptoms of the virus by 77%.

Known as AZD7442, it is the first non-vaccine antibody drug to provide lasting protection to COVID, AstraZeneca said. If approved, it would be the first of its kind to receive an EUA for COVID prevention.

“With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines,” Mene Pangalos, executive vice-president of AstraZeneca, said.

In August, the company announced the results of its Phase III trials, which it said showed the drug was highly effective in reducing risk of COVID infection. More than 75% of people in the test group had complicating factors that could heighten the dangerousness of the virus.

“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,” Pangalos said. The company’s hope is that the drug can provide added immune protection for those people.

AstraZeneca has also developed a vaccine used in other parts of the world, but it is not among the three approved under EUAs in the United States.