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Hemlibra Clinical Development Timeline

Executive Summary

Chronicle of the development and US FDA review of Genentech's emicizumab-kxwh for hemophilia A.

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

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.

US FDA Sought Patient Viewpoint On Hemlibra's Benefit/Risk Profile

Hemophilia patient advocate expressed concerns to FDA about ability of hemophilia treatment centers to educate patients about thrombotic microangiopathy and thromboembolic events, unexpected but serious cases of which were seen in the clinical program.

US FDA Sought Patient Viewpoint On Hemlibra's Benefit/Risk Profile

Hemophilia patient advocate expressed concerns to FDA about ability of hemophilia treatment centers to educate patients about thrombotic microangiopathy and thromboembolic events, unexpected but serious cases of which were seen in the clinical program.

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