MedPath

Emicizumab

Generic Name
Emicizumab
Brand Names
Hemlibra
Drug Type
Biotech
CAS Number
1610943-06-0
Unique Ingredient Identifier
7NL2E3F6K3

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.

Background

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.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Emicizumab Injection
国药准字SJ20180028
生物制品
注射剂
8/24/2023
Emicizumab Injection
国药准字SJ20180026
生物制品
注射剂
8/24/2023
Emicizumab Injection
国药准字SJ20180025
生物制品
注射剂
8/24/2023
Emicizumab Injection
国药准字SJ20180027
生物制品
注射剂
8/24/2023
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