USFDA withdraws emergency use authorization for AstraZeneca COVID 19 treatment Evusheld

AstraZeneca said it was informed that the agency will decide about reinstating authorization of Evusheld if the prevalence of resistant variants in the United States decreases to 90 percent or less on a sustained basis.

Published On 2023-01-27 11:12 GMT   |   Update On 2023-01-27 11:12 GMT
Advertisement

US: The U.S. health regulator has withdrawn emergency-use authorization for AstraZeneca's COVID-19 antibody cocktail Evusheld as the treatment is not expected to neutralize the currently dominant XBB.1.5 subvariant of Omicron.

The Food and Drug Administration (FDA) had limited Evusheld's use earlier this month for the same reason.

Omicron subvariant XBB.1.5 has been spreading rapidly in the country since December and it made up nearly half of all U.S. COVID-19 cases last week, according to government data.

Advertisement

The FDA's decision resonates with concerns raised by the European health regulator about the effectiveness of monoclonal antibodies such as Evusheld against newer variants.

AstraZeneca said it was informed that the agency will decide about reinstating authorization of Evusheld if the prevalence of resistant variants in the United States decreases to 90% or less on a sustained basis.

The drugmaker plans to continue to share relevant data with the FDA and other health authorities regarding Evusheld and SARS-CoV-2 variants.

Monoclonal antibodies act by binding to the spike protein on the surface of the SARS-CoV-2 virus, but the virus has been evolving, causing changes in this protein and affecting how the antibodies work against them.

In November, the U.S. health regulator also pulled emergency use authorization for Eli Lilly and Co's COVID-19 drug bebtelovimab, citing similar concerns.

Read also: COVID-19 Treatment : Eli Lilly's Bebtelovimab no longer authorized by USFDA

Evusheld was first authorized in late 2021 by the FDA to prevent COVID-19 infections in individuals with weak immune systems or a history of severe side effects from coronavirus vaccines

Tags:    
Article Source : Reuters

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News