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EU regulator advises AstraZeneca’s COVID drug to be authorized

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Covid Antibody Drug virus outbreak (Copyright 2022 The Associated Press. All rights reserved).

The European Union’s medicines regulator said on Thursday it was recommending that an antibody drug developed by AstraZeneca be authorized to help some vulnerable people avoid getting sick from the coronavirus.

The European Medicines Agency said in a statement that it advised that the new drug, sold as Evusheld, be used in people over 12 years of age before they were exposed to COVID-19, to prevent future infections.

The drug was previously approved by the US Food and Drug Administration in December for people with serious health problems or allergies who can’t get adequate protection from vaccination. Britain also authorized Evusheld last week.

“When the antibodies in Evusheld attach to the spike protein, the virus cannot enter cells to multiply and cannot cause a COVID-19 infection,” the EMA said. The agency said it evaluated data on the drug from more than 5,000 people and found that Evusheld reduced the risk of infection by 77%, with protection estimated to last at least six months.

The EMA said side effects from the drug were mostly mild, with some people reporting reactions where the drug was injected. The agency noted that the research was done before the highly infectious omicron variant emerged and said it was evaluating data to determine whether a different dose might be necessary.

Although antibody drugs have been a standard treatment for treating COVID-19 infections for more than a year, AstraZeneca’s antibody drug is the first aimed at long-term prevention against COVID-19 infection, rather than of short-term treatment.

People who might benefit from the antibody drug include cancer patients, organ transplant recipients, and people taking immunosuppressive drugs for conditions such as rheumatoid arthritis.


Follow AP’s coverage of the pandemic at https://apnews.com/hub/coronavirus-pandemic

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