Overview
Recombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Background
Recombinant Coagulation Factor IX is a purified Factor IX glycoprotein produced by recombinant DNA technology. It has a primary amino acid sequence that is identical to the Ala148 allelic form of human factor IX, and has structural and functional characteristics similar to those of endogenous factor IX. It is not derived from human blood (unlike human Factor IX complex), and is instead produced by a genetically engineered Chinese hamster ovary (CHO) cell line that secretes recombinant Factor IX into cell medium that is then processed and purified for use as a pharmaceutical agent. Recombinant Factor IX is indicated for the control and prevention of bleeding episodes in adult and pediatric patients with congenital factor IX deficiency (Hemophilia B).
Indication
For treatment of hemophilia (Christmas disease).
Associated Conditions
- Bleeding
- Hemophilia B
- Perioperative bleeding caused by Hemophilia B
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2017/03/27 | Phase 2 | Completed | |||
2015/01/12 | Phase 4 | Completed | |||
2014/08/11 | Phase 1 | Completed | |||
2009/12/07 | Phase 3 | Completed | |||
2008/07/14 | N/A | Completed | |||
2007/06/08 | N/A | Completed | |||
2004/10/07 | Phase 3 | Completed | Wyeth is now a wholly owned subsidiary of Pfizer | ||
2004/10/07 | Phase 3 | Completed | Wyeth is now a wholly owned subsidiary of Pfizer | ||
2002/05/20 | Phase 3 | Completed | Wyeth is now a wholly owned subsidiary of Pfizer |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 12/19/2014 | ||
Authorised | 8/27/1997 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| BeneFIX Powder and Solvent for Solution for Injection 500iu/vial | SIN13804P | INJECTION, POWDER, FOR SOLUTION | 500IU/vial(138IU/mL) | 5/20/2010 | |
| BeneFIX Powder and Solvent for Solution for Injection 2000iu/vial | SIN13806P | INJECTION, POWDER, FOR SOLUTION | 2000IU/vial(550IU/mL) | 5/20/2010 | |
| BeneFIX Powder and Solvent for Solution for Injection 1000iu/vial | SIN13805P | INJECTION, POWDER, FOR SOLUTION | 1000IU/vial(275IU/mL) | 5/20/2010 | |
| BeneFIX Powder and Solvent for Solution for Injection 250iu/vial | SIN13803P | INJECTION, POWDER, FOR SOLUTION | 250IU/vial (69IU/mL) | 5/20/2010 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||