Saturday, October 23, 2021

AstraZeneca seeks FDA emergency approval for antibody COVID-19 drug

6th October (WNN) — AstraZeneca has asked the US Food and Drug Administration to grant emergency authorization for its long-acting antibody treatment to prevent symptomatic COVID-19 in people at high risk of the disease.

The British-Swedish company submitted its request to the federal agency on Tuesday, the company said in a statement, saying if approved it would be the first treatment of its kind to be authorized for use in the country.

Mene Pangalos, executive vice president of biopharmaceuticals research and development with AstraZeneca, said, “Vulnerable populations, such as the immunocompromised, are not able to mount a protective response after vaccination and are at risk of developing COVID-19. ” “With this first global regulatory filing, we are closer to providing vaccines as well as an additional option to help protect against COVID-19.”

In August AstraZeneca announced its late-stage human trials of a drug called AZD7442, which it said was 77% effective in reducing the risk of developing COVID-19 in people with co-morbidities and those with the virus. Additional protection may be required. The drug was also more than 75% effective in participants who suffered from conditions that put them at risk for serious illness or who had a low immune response to the vaccine.

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The drug, the company said, is being studied for both prevention and treatment of COVID-19 in more than 9,000 participants, and is being developed with US government support and funding from the Department of Health and Human Services.

When it announced its late trial results on August 20, AstraZeneca explained the drug, which is delivered by intramuscular injection, could provide up to 12 months of protection against the virus.

Myron Levin, a professor of pediatrics and medicine at the University of Colorado School of Medicine and principal investigator of the US trial of the drug, said the data shows that a single dose of the drug “quickly and effectively symptomatic COVID-19.” can stop it.”

“With these exciting results, AZD7442 could be a valuable tool in our arsenal to help those who need more than a vaccine to return to their normal lives,” he said in a statement in August.

AstraZeneca was also one of the first companies to produce a COVID-19 vaccine, but it is not approved for use in the United States, although several other countries have. The World Health Organization has also listed it for emergency use.

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