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Hemlibra Approval History

FDA Approved: Yes (First approved November 16, 2017)
Brand name: Hemlibra
Generic name: emicizumab-kxwh
Dosage form: Injection
Company: Genentech, Inc.
Treatment for: Hemophilia A with Inhibitors, Hemophilia A

Hemlibra (emicizumab-kxwh) is a bispecific factor IXa- and factor X-directed antibody indicated to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.

Development History and FDA Approval Process for Hemlibra

DateArticle
Oct  4, 2018Approval FDA Approves Genentech’s Hemlibra (emicizumab-kxwh) for Hemophilia A Without Factor VIII Inhibitors
Apr 16, 2018FDA Grants Breakthrough Therapy Designation For Genentech’s Hemlibra (emicizumab-kxwh) in Hemophilia A Without Inhibitors
Nov 16, 2017Approval FDA Approves Hemlibra (emicizumab-kxwh) for Hemophilia A with Inhibitors
Aug 23, 2017FDA Grants Priority Review to Genentech's Emicizumab for Hemophilia A with Inhibitors
Jun 25, 2017Genentech’s Emicizumab Showed Positive Results in Phase III Studies (HAVEN 1 And HAVEN 2) in Hemophilia A With Inhibitors
Apr 16, 2017Genentech Announces Positive Interim Results for Emicizumab in Phase III Study of Children with Hemophilia A
Dec 22, 2016Roche’s Emicizumab for Hemophilia A Meets Primary Endpoint in Phase III Study

Further information

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