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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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.