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Updates to Expand Eligibility Criteria for Monoclonal Antibody Therapies

May 25, 2021

The Office of the Assistant Secretary for Preparedness and Response recently e-mailed important updates to expand the eligibility criteria for two monoclonal antibody therapies—bamlanivimab and etesevimab administered together—and the combination therapy casirivimab/imdevimab. According to the Food and Drug Administration’s emergency use authorization, both therapies are used to treat mild to moderate COVID-19 in patients at high risk of progressing to severe COVID-19 and/or hospitalization.

The FDA’s updates expand the definition of high-risk patients by:

  • eliminating specific thresholds for defining older age
  • removing specific body mass index thresholds in defining overweight and obese individuals
  • not limiting the definition of high risk to specific medical conditions and factors

GNYHA strongly encourages hospitals to review the updated eligibility criteria in the bamlanivimab and etesevimab and casirivimab/imdevimab factsheets.

Please contact Zeynep Sumer King with questions about COVID-19 and Amy Chin with questions about the monoclonal antibody therapies and reporting.