EU regulator advises AstraZeneca’s COVID drug to be cleared | Nation and business

LONDON (AP) — The European Union’s medicines regulator said Thursday it is recommending that an antibody drug developed by AstraZeneca be authorized to help certain vulnerable people avoid getting sick with the coronavirus.

The European Medicines Agency said in a statement it was advising the use of the new drug, sold as Evusheld, in people aged 12 and over before they are exposed to COVID-19. , to prevent future infections.

It is now up to the EU’s executive body, the European Commission, to officially authorize the drug.

The United States Food and Drug Administration cleared the medicine in December for people with serious health problems or allergies that cannot be sufficiently protected by vaccination. Britain cleared the use of Evusheld last week.

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

The EMA said the drug’s side effects were mostly mild, with some people reporting reactions at the injection site. The agency noted that research had been done before the highly infectious omicron variant emerged and said it was evaluating the data to determine if a different dose might be needed.

Although antibodies have been a standard treatment for treating COVID-19 infections for more than a year, AstraZeneca’s is the first intended for long-term prevention against COVID-19 infection rather than a short-term treatment.

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


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