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# Genentech sBLA for Hemlibra Gains Priority Review
- URL: https://www.fdaweb.com/genentech-sbla-for-hemlibra-gains-priority-review/
- Published: 2018-06-05T12:00:00.000Z
- Updated: 2026-09-15T00:10:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141604

FDA has accepted for priority review a Genentech supplemental BLA for Hemlibra (emicizumab-kxwh) for adults and children with hemophilia A without factor VIII inhibitors. The submission is based on data from the Phase 3 HAVEN 3 study. In the study, adults and adolescents with hemophilia A without factor VIII inhibitors who received Hemlibra prophylaxis every week or every two weeks showed about a 96% reduction in treated bleeds compared to those who received no prophylaxis, according to the company. The agency is expected to make a decision on approval by 10/4.