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# FDA OKs Genentech’s Hemlibra for Some Hep A
- URL: https://www.fdaweb.com/fda-oks-genentechs-hemlibra-for-some-hep-a/
- Published: 2018-10-04T12:00:00.000Z
- Updated: 2026-09-15T00:35:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142522

FDA has approved Genetech’s Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A without factor VIII inhibitors. The company [says](https://www.marketwatch.com/press-release/fda-approves-genentechs-hemlibraemicizumab-kxwh-for-hemophilia-a-without-factor-viii-inhibitors-2018-10-04?ref=fdaweb.com) Hemlibra is the only prophylactic treatment for people with hemophilia A and without factor VIII inhibitors that can be administered subcutaneously and at multiple dosing options.

The approval was based on positive results from the Phase 3 HAVEN 3 and HAVEN 4 studies in which the drug reportedly led to statistically significant and clinically meaningful reductions in treated bleeds compared to no prophylaxis.

Hemlibra was granted breakthrough designation for hemophilia A without factor VIII inhibitors. It also was granted priority review. The product was approved by FDA 11/2017 for adults and children with hemophilia A with factor VIII inhibitors.