Emicizumab (Hemlibra)
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Mechanism of action
A recombinant, humanized, bispecific monoclonal antibody that bridges activated factor IX and factor X to restore the function of missing activated factor VIII.
Diseases for which it is used
- Acquired factor VIII inhibitor in the setting of inherited factor VIII deficiency
- Acquired hemophilia A
History of changes in FDA indication
- 2017-11-16: Approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.
- 2018-10-04: Approval expanded for prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (ages newborn and older) with hemophilia A (congenital factor VIII deficiency) with or without factor VIII (FVIII) inhibitors. (requirement for inhibitor to be present was removed)
History of changes in EMA indication
- 2018-02-23: Initial authorisation
- Uncertain date: Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors. Hemlibra can be used in all age groups.
- 2023-03-06: Indicated revised to include patients with haemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors who have severe disease (FVIII < 1%) or moderate disease (FVIII at least 1% and up to 5%) with severe bleeding phenotype. Hemlibra can be used in all age groups.
History of changes in PMDA indication
- 2022-06-20: Drugs with a new indication and a new dosage for the control of bleeding tendency in patients with acquired hemophilia A.
Also known as
- Code name: ACE-910
- Generic name: emicizumab-kxwh
- Brand name: Hemlibra