Overview
Vonicog alfa is a recombinant von Willebrand factor manufactured by Baxalta. It was FDA approved in December 2015. The gen of von Willebrand factor was first cloned in 1985 by Stuart Orkin and David Ginsburg. By the EMA, vonicog alfa is still under clinical analysis.
Indication
Vonicog alfa is indicated for the on-demand treatment and control of bleeding episodes in adults previously diagnosed with von Willebrand disease. Vonicog alfa contains only the vWF and thus, its administration offers the flexibility to administer the coagulation factor VIII if needed. The von Willebrand disease is an inherited disorder characterized by the deficiency or misfunction of the von Willebrand factor (vWF). Due to this deficiency, the blood cannot clot properly and the patients that present this disease are prone to prolonged or excessive bleeding. There are three types of this disease, and type 3 is an autosomal recessive inherited disorder marked by very low or absent levels of vWF.
Associated Conditions
- Bleeding
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/12/15 | N/A | AVAILABLE | |||
2022/10/17 | Phase 3 | Recruiting | |||
2019/03/18 | Phase 3 | Completed | Baxalta now part of Shire | ||
2016/10/13 | Phase 3 | Recruiting | Baxalta now part of Shire |
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 | 8/31/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ADVATE 500 IU Powder and Solvent for Solution for Injection | SIN13497P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 500 IU | 7/16/2008 | |
| ADVATE 250 IU Powder and Solvent for Solution for Injection | SIN13492P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 250 IU | 7/16/2008 | |
| ADVATE 1500 IU Powder and Solvent for Solution for Injection | SIN13493P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 1500 IU | 7/16/2008 | |
| ADVATE 1000 IU Powder and Solvent for Solution for Injection | SIN13496P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 1000 IU | 7/16/2008 |
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 |
|---|---|---|---|---|---|
| VEYVONDI vonicog alfa 1300 IU powder for injection with solvent vials | 316660 | Medicine | A | 4/20/2020 | |
| VEYVONDI vonicog alfa 650 IU powder for injection with solvent vials | 316659 | Medicine | A | 4/20/2020 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
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. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.