Overview
In recent years, various extended half-life factor VIII and factor IX preparations have been studied and gained approval. In order to extend half-lives, techniques such as fusion to protein conjugates (Fc part of IgG1 or albumin), chemical modification (PEGylation), and protein sequence modification have been utilized. Also known as, BAY94-9027, Damoctocog alfa pegol is a longer-acting Factor VIII therapy formulated with polyethylene glycol (PEG) to reduce the number of infusions necessary to prevent bleeds in patients diagnosed with Haemophilia A. This product has been engineered by Bayer and a biological license application has been filed with the FDA in August 2017 and FDA approved in August 2018.
Indication
Indicated for use in previously treated adults and adolescents (12 years of age and above) with hemophilia A (congenital Factor VIII deficiency) for: On-demand treatment and control of bleeding episodes , perioperative management of bleeding , and routine prophylaxis to reduce the frequency of bleeding episodes .
Associated Conditions
- Hemophilia A
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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No clinical trials found
No clinical trials found for this drug
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 | 11/22/2018 | ||
Authorised | 11/22/2018 | ||
Authorised | 11/22/2018 | ||
Authorised | 11/22/2018 | ||
Authorised | 11/22/2018 | ||
Authorised | 11/22/2018 | ||
Authorised | 11/22/2018 | ||
Authorised | 11/22/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
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. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| JIVI damoctocog alfa pegol 3000 IU powder for injection vial with diluent syringe | 384591 | Medicine | A | 3/27/2023 | |
| JIVI damoctocog alfa pegol 500 IU powder for injection vial with diluent syringe | 384592 | Medicine | A | 3/27/2023 | |
| JIVI damoctocog alfa pegol 2000 IU powder for injection vial with diluent syringe | 384593 | Medicine | A | 3/27/2023 | |
| JIVI damoctocog alfa pegol 1000 IU powder for injection vial with diluent syringe | 384594 | Medicine | A | 3/27/2023 | |
| JIVI damoctocog alfa pegol 250 IU powder for injection vial with diluent syringe | 384590 | Medicine | A | 3/27/2023 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| JIVI 500 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 1181324002 | POLVO Y SOLUCIÓN PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| JIVI 1000 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 1181324003 | POLVO Y SOLUCIÓN PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| JIVI 2000 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 1181324004 | POLVO Y SOLUCIÓN PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| JIVI 3000 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 1181324005 | POLVO Y SOLUCIÓN PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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