The Food and Drug Administration has withdrawn emergency. Use approval of AstraZeneca’s Covid-19 antibody cocktail Evusheld because. The treatment is not expected to neutralize. The currently dominant XBB.1.5subvariant of Omicron.
The FDA restricted the use of IvuShield earlier this month for the same reason. And the company’s Thursday announcement sent U.S. shares of London-based AstraZeneca down 1.31% to $65.75.
The Omicron subvariant XBB.1.5 has been spreading rapidly. In the country since December and accounted. For nearly half of all U.S. Covid cases last week, according to government data.
The FDA’s decision resonates with concerns raised by European health regulators. About the effectiveness of monoclonal antibodies such as Evushield against the new variants.
AstraZeneca said the agency will decide whether to reinstate Evusheld’s approval. If the prevalence Covid of resistant variants in the US is 90% or less on a sustained basis.
The drugmaker plans to share relevant data about Evusheld. And the SARS-CoV-2 variant with the FDA and other health authorities.
Monoclonal antibodies work by binding to the spike protein on. The surface of the SARS-CoV-2 virus. But the virus is evolving, causing changes. In these proteins and affecting how antibodies work Covid against them.
In November, US health regulators also pulled emergency use approval. For Eli Lilly’s drug bebetelovimab, citing similar concerns.
Evusheld was first approved by the FDA in late 2021 to prevent Covid infection. In people with weakened immune systems or a history. Of serious side effects from the coronavirus vaccine.
