Difference between revisions of "Emicizumab (Hemlibra)"
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| − | =Mechanism of action= | + | ==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. | 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= | + | ==Diseases for which it is used== |
| − | *[[ | + | *[[Hemophilia A|Acquired factor VIII inhibitor in the setting of inherited factor VIII deficiency]] |
| + | *[[Acquired hemophilia A]] | ||
| − | =History of changes in FDA indication= | + | ==History of changes in FDA indication== |
| − | *11 | + | *2017-11-16: Approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with [[Hemophilia A|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|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 [[Hemophilia A|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 [[Hemophilia A|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= | =Also known as= | ||
| − | *'''Code name:''' | + | *'''Code name:''' ACE-910 |
| + | *'''Generic name:''' emicizumab-kxwh | ||
*'''Brand name:''' Hemlibra | *'''Brand name:''' Hemlibra | ||
| − | [[Category: | + | [[Category:Drugs]] |
[[Category:Subcutaneous medications]] | [[Category:Subcutaneous medications]] | ||
| − | + | [[Category:Anti-Factor IXa-Factor Xa bispecific antibodies]] | |
| − | [[Category:Anti-Factor IXa | ||
| − | |||
| − | [[Category: | + | [[Category:Inherited coagulopathy medications]] |
| − | [[Category: | + | [[Category:FDA approved in 2017]] |
| + | [[Category:EMA approved in 2018]] | ||
Latest revision as of 00:21, 18 October 2023
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