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First Three Novel Biologic Suffixes Came Courtesy Of US FDA, Not Sponsors

Executive Summary

FDA assigned a four-letter nonproprietary name suffix to Genentech's Hemlibra because an expedited review left little time to evaluate the sponsor's late-submitted proposals; UltraGenyx asked FDA to assign one for Mepsevii, while Spark submitted 10 suffix candidates for Luxturna only to see all of them rejected for being too meaningful.

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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.

Hemlibra Clinical Development Timeline

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

Hemlibra Reviewers

US FDA staff who participated in the review of Genentech's hemophilia A treatment emicizumab-kxwh.

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