Damoctocog alfa pegol
- Generic Name
- Damoctocog alfa pegol
- Brand Names
- Jivi
- Drug Type
- Biotech
- CAS Number
- 1363853-26-2
- Unique Ingredient Identifier
- BY4TSK952Y
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.
Background
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 Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
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No FDA products found
No FDA products found for this drug
EMA Approved Products
Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|---|---|---|---|---|---|---|---|
EMEA/H/C/004054 | Germany | N/A | Authorised | 2018/11/22 | 2018/09/20 | 5 |
HSA Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. |
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No HSA products found
No HSA products found for this drug
NMPA Approved Products
Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
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No NMPA products found
No NMPA products found for this drug
PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Reg. Date |
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No PPB products found
No PPB products found for this drug
TGA Approved Products
Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
|---|---|---|---|---|---|
384591 | Active | 2023/03/27 | damoctocog alfa pegol | ||
384592 | Active | 2023/03/27 | damoctocog alfa pegol | ||
384593 | Active | 2023/03/27 | damoctocog alfa pegol | ||
384594 | Active | 2023/03/27 | damoctocog alfa pegol | ||
384590 | Active | 2023/03/27 | damoctocog alfa pegol |