Overview
Emicizumab is a humanized recombinant monoclonal antibody that mimics the function of the coagulation Factor VIII and it has the capacity to bind simultaneously to activated Factor IX and Factor X. The ability of Emicizumab to bind to all these three different factors allows it to overcome immunogenicity and unstable hemostatic efficacy produced by previous Factor VII agents. Emicizumab was originated as an improved form of hBS23 and it was approved on November 16, 2017. It was created by Chugai Pharmaceuticals Co. Ltd. and co-developed with Roche and Genentech.
Indication
The main function of Emicizumab is the prevention of bleeding episodes. Thus, Emicizumab is approved for the routine prophylaxis to prevent or reduce the frequency of bleeding episodes of adult and pediatric patients with hemophilia A with or without Factor VIII inhibitors. Hemophilia A is a deficiency of coagulation Factor VIII which causes a serious bleeding disorder. The standard treatment is done with the administration of recombinant or serum-deriver Factor VIII which induces the formation of anti-factor VIII alloantibodies (Factor VIII inhibitors) and renders the standard treatment ineffective.
Associated Conditions
- Bleeding caused by Hemophilia A
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/31 | Phase 3 | Recruiting | |||
2025/04/22 | Phase 2 | Not yet recruiting | |||
2023/10/27 | N/A | Not yet recruiting | |||
2022/08/15 | Phase 1 | Recruiting | Bleeding and Clotting Disorders Institute Peoria, Illinois | ||
2022/04/25 | Phase 2 | Recruiting | |||
2022/03/15 | Not Applicable | Completed | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | ||
2022/02/21 | N/A | Recruiting | |||
2022/01/06 | Phase 4 | Active, not recruiting | |||
2021/08/26 | N/A | Recruiting | |||
2021/03/18 | N/A | Recruiting | JW Pharmaceutical |
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 | 2/23/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| HEMLIBRA SOLUTION FOR INJECTION 30MG/ML | SIN15577P | INJECTION, SOLUTION | 30 mg/mL | 11/9/2018 | |
| HEMLIBRA SOLUTION FOR INJECTION 150MG/ML | SIN15576P | INJECTION, SOLUTION | 150mg/ml | 11/9/2018 |
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 |
|---|---|---|---|---|---|
| HEMLIBRA SOLUTION FOR INJECTION 60MG/0.4ML | N/A | N/A | N/A | 10/20/2018 | |
| HEMLIBRA SOLUTION FOR INJECTION 150MG/1ML | N/A | N/A | N/A | 10/20/2018 | |
| HEMLIBRA SOLUTION FOR INJECTION 105MG/0.7ML | N/A | N/A | N/A | 10/20/2018 | |
| HEMLIBRA SOLUTION FOR INJECTION 30MG/1ML | N/A | N/A | N/A | 10/20/2018 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| HEMLIBRA emicizumab (rch) 60 mg/0.4 mL solution for injection vial | 293760 | Medicine | A | 2/23/2018 | |
| HEMLIBRA emicizumab (rch) 30 mg/1 mL solution for injection vial | 293761 | Medicine | A | 2/23/2018 | |
| HEMLIBRA emicizumab (rch) 150 mg/1 mL solution for injection vial | 293759 | Medicine | A | 2/23/2018 | |
| HEMLIBRA emicizumab (rch) 105 mg/0.7 mL solution for injection vial | 293758 | Medicine | A | 2/23/2018 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| HEMLIBRA | Hoffmann-La Roche Limited | 02479656 | Solution - Subcutaneous | 105 MG / 0.7 ML | 2/21/2019 |
| HEMLIBRA | Hoffmann-La Roche Limited | 02479648 | Solution - Subcutaneous | 60 MG / 0.4 ML | 10/19/2018 |
| HEMLIBRA | Hoffmann-La Roche Limited | 02556049 | Solution - Subcutaneous | 12 MG / 0.4 ML | N/A |
| HEMLIBRA | Hoffmann-La Roche Limited | 02479664 | Solution - Subcutaneous | 150 MG / ML | 11/27/2018 |
| HEMLIBRA | Hoffmann-La Roche Limited | 02556057 | Solution - Subcutaneous | 300 MG / 2 ML | N/A |
| HEMLIBRA | Hoffmann-La Roche Limited | 02479621 | Solution - Subcutaneous | 30 MG / 1 ML | 10/19/2018 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| HEMLIBRA 150 MG/ML SOLUCION INYECTABLE | 1181271002 | SOLUCIÓN INYECTABLE | Diagnóstico Hospitalario | Commercialized | |
| HEMLIBRA 30 MG/ML SOLUCION INYECTABLE | 1181271001 | SOLUCIÓN INYECTABLE | Diagnóstico 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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