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# FDA Approves Hemlibra for Hemphilia A Bleeding
- URL: https://www.fdaweb.com/fda-approves-hemlibra-for-hemphilia-a-bleeding/
- Published: 2017-11-16T12:00:00.000Z
- Updated: 2026-09-14T23:02:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140150

FDA has approved Genentech’s Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII inhibitors. An FDA [announcement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585567.htm?ref=fdaweb.com) says that Hemlibra is a first-in-class therapy that works by bridging other Factors in the blood to restore blood clotting for these patients. It is a prophylactic treatment given weekly through subcutaneous injection.

Hemlibra’s safety and effectiveness were determined through two clinical trials. Common side effects include injection site reactions, headache, and arthralgia.

The drug’s labeling includes a Boxed Warning that thrombotic microangiopathy and thromboembolism have been observed in patients who were also given a rescue treatment (activated prothrombin complex concentrate) to treat bleeds for 24 hours or more while taking Hemlibra.

The Genentech application received priority review and breakthrough therapy designations, as well as an orphan drug designation.