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Genentech's Hemlibra: Clinical Outcome Assessment Data Only Partially Swayed US FDA

Executive Summary

Hemophilia A drug's labeling reflects data on physical function improvement because FDA deemed that portion of the Haem-A-QoL instrument fit for purpose, while other questions were viewed as insensitive to change or irrelevant. Review documents suggest agency was unimpressed with results from a health status instrument frequently used in economic analyses.

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