MedPath

Faricimab

Generic Name
Faricimab
Brand Names
Vabysmo
Drug Type
Biotech
CAS Number
1607793-29-2
Unique Ingredient Identifier
QC4F7FKK7I

Overview

Retinal vascular diseases (RVDs) such as diabetic macular edema (DME), age-related macular degeneration (AMD), and retinal vein occlusion (RVO) are typically caused by retinal ischemia and subsequent neovascularization (NV). Vascular endothelial growth factor A (VEGF-A) is a well-known mediator of retinal NV, and many currently approved RVD therapies such as aflibercept and ranibizumab solely target VEGF-A. However, another set of factors, the Tie/Ang axis, comprising the transmembrane Tie-2 receptor and its soluble ligands Ang-1 and Ang-2, has been shown to play critical roles in mediating VEGF-A-induced NV. Faricimab is an IgG-derived bispecific antibody capable of simultaneously binding to and depleting VEGF-A and Ang-2, which has been developed to improve therapeutic efficacy, especially in patients that respond poorly to anti-VEGF-A monotherapy. Faricimab was approved by the FDA on January 28, 2022, and is currently marketed under the trademark VABYSMO by Genentech, Inc. It received subsequent approval for the same indications in Canada in May 2022. In July 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended faricimab be granted marketing authorization for the treatment of neovascular age-related macular degeneration and diabetic macular edema.

Indication

Faricimab is indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).

Associated Conditions

  • Diabetic Macular Edema (DME)
  • Neovascular Age-Related Macular Degeneration (nAMD)
  • Visual Impairment

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/08/28
Not Applicable
Completed
Bojie Hu
2025/07/30
Not Applicable
Completed
Baghdad college of medicine
2025/07/28
N/A
Not yet recruiting
Hui Peng
2025/04/03
Phase 2
Recruiting
Innovent Biologics Technology Limited (Shanghai R&D Center)
2025/03/30
N/A
Completed
2025/03/21
N/A
Active, not recruiting
2025/03/13
Phase 4
Recruiting
Faculty Hospital Kralovske Vinohrady
2025/02/28
Phase 1
Recruiting
2025/01/27
Phase 4
Recruiting
2025/01/24
Phase 3
Not yet recruiting
Jaeb Center for Health Research

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Genentech, Inc.
50242-096
INTRAVITREAL
6 mg in 0.05 mL
10/31/2023

EMA Drug Approvals

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
VABYSMO SOLUTION FOR INJECTION 6MG/0.05ML
SIN16514P
INJECTION, SOLUTION
6.00mg/0.05ml
6/16/2022

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
VABYSMO SOLUTION FOR INTRAVITREAL INJECTION 6MG/0.05ML
N/A
N/A
N/A
12/15/2022
VABYSMO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 6MG/0.05ML
N/A
N/A
N/A
6/23/2025

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
VABYSMO faricimab 120 mg/mL solution for injection in a pre-filled syringe
449965
Medicine
A
9/30/2024
VABYSMO faricimab 120 mg/mL solution for injection vial
369935
Medicine
A
8/8/2022

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
VABYSMO
Hoffmann-La Roche Limited
02554003
Solution - Intravitreal
6 MG / 0.05 ML
N/A
VABYSMO
Hoffmann-La Roche Limited
02527618
Solution - Intravitreal
6 MG / 0.05 ML
7/18/2022

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
VABYSMO 120 MG/ML SOLUCION INYECTABLE
1221683001
SOLUCIÓN INYECTABLE
Uso Hospitalario
Commercialized
VABYSMO 120 MG/ML SOLUCION PARA INYECCION EN JERINGA PRECARGADA
1221683002
SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA
Uso Hospitalario
Commercialized
VABYSMO 120 MG/ML SOLUCION INYECTABLE
1221683001IP
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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