Friday, August 27, 2021

Resumption in Use and Distribution of Bamlanivimab/Etesevimab in Certain States - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

Resumption in Use and Distribution of Bamlanivimab/Etesevimab in Certain States 

Today, the Food and Drug Administration and the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services are informing you of changes in the authorized use of bamlanivimab and etesevimab administered together under Emergency Use Authorization (EUA) 094. Specifically, the EUA now authorizes the use of bamlanivimab and etesevimab, administered together, only in states, territories, and U.S. jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to 5%. Bamlanivimab and etesevimab administered together will not be authorized for use in states, territories, and U.S. jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together exceeds 5%. 

FDA has posted a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab administered together are currently authorized, and a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab administered together are not currently authorized and will periodically update both lists as new data and information becomes available. FDA will make this determination considering current variant frequency data, trends in variant frequency over time, and the precision of the estimates and information regarding emerging variants of concern. 

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