The US Food and Drug Administration (FDA) has withdrawn the emergency use authorization for AstraZeneca’s Evusheld drug. In the photo: AstraZeneca headquarters in Wilmington, Delaware (USA) – Photo: REUTERS
The FDA’s announcement to withdraw the drug Evusheld’s license on January 26 caused AstraZeneca’s shares in the US to drop 1.31%, to $ 65.75.
Earlier in January, the FDA restricted the use of the drug Evosheld. According to the FDA, Evusheld’s treatment will not disable Omicron’s XBB.1.5 sub-variant, which currently dominates.
Omicron’s XBB.1.5 sub-variant has spread rapidly in the country since December 2022 and accounted for nearly half of all US COVID-19 cases last week, according to US government data.
The FDA’s decision resonates with European health regulators’ concerns about the effectiveness of monoclonal antibodies like Evusheld on newer variants.
AstraZeneca said it was told by the FDA that it would reinstate the license for Evusheld if the rate of the drug-resistant variant in the US drops to 90%.
Monoclonal antibodies work by binding to the spike protein on the surface of the SARS-CoV-2 virus. However, viruses have been evolving, causing changes in this protein and affecting how antibodies work against them.
In November 2022, the US health regulator also withdrew the emergency use authorization for the COVID-19 drug Bebtelovimab by Eli Lilly and Co, citing similar concerns.