Faricimab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2022
- First approval year
- 2022
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Faricimab
- vabysmo
- Vabysmo
- faricimab
- Faricimab
- faricimab [INN]
- FARICIMAB [JAN]
- Faricimab [MI]
- FARICIMAB [USAN]
- Faricimab [WHO-DD]
- Faricimab Injection
- faricimab inn
- faricimab jan
- faricimab mi
- faricimab svoa
- Faricimab svoa
- Faricimab svoa [WHO-DD]
- faricimab svoa who dd
- faricimab usan
- faricimab who dd
- Faricimab-svoa
- rg 7716
- rg 7716 antivascular endothelial growth factor anti angiopoietin 2 bispecific antibody
- Rg-7716
- RG-7716 (ANTIVASCULAR ENDOTHELIAL GROWTH FACTOR/ANTI-ANGIOPOIETIN 2 BISPECIFIC ANTIBODY)
- rg7716
- RG7716
- rg77161
And 10 more, listed on the interactive page.
- CAS registry numbers
- 1607793-29-2
- ChEMBL ID
- CHEMBL4297750
- FDA ingredient codes (UNII)
- QC4F7FKK7I
- S01L
- S01LA09
Sources for recorded values
- 2591519
- 2591584
- Applicant
- GENENTECH INC
- Approval date
- 28 Jan 2022
- Application number
- BLA761235
- Status
- Authorised
- Status date
- 15 Sept 2022
- Authorisation date
- 15 Sept 2022
- Approved indications
- Vabysmo is indicated for the treatment of adult patients with: neovascular (wet) age-related macular degeneration (nAMD), visual impairment due to diabetic macular oedema (DME), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).
- Product number
- EMEA/H/C/005642
- Authorisation holder
- Roche Registration GmbH
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Diabetes Complications
- Macular Edema
- Wet Macular Degeneration
European medicines record
- Patents
- 0
- Designations
- 1
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- faricimab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- angiopoietin-2
- Gene symbol
- angiopoietin-2
- Median affinity
- 7.66
- Affinity units
- pKd
- Primary target
- Yes
- Action
- Binding
- Action type
- Binding
- Target
- VEGFA
- Gene symbol
- VEGFA
- Median affinity
- 8.52
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- Angiopoietin-2 inhibitor
- Action type
- Inhibitor
- Target
- Angiopoietin-2
- Protein identifier
- O15123
- Mechanism
- Vascular endothelial growth factor A inhibitor
- Action type
- Inhibitor
- Target
- Vascular endothelial growth factor A, long form
- Protein identifier
- P15692
- Mechanism
- Angiopoietin-2 inhibitor
- Action type
- Inhibitor
- Target
- Angiopoietin-2
- Mechanism
- Vascular endothelial growth factor A inhibitor
- Action type
- Inhibitor
- Target
- Vascular endothelial growth factor A, long form
- Condition
- Macular Degeneration
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001365
- Subject identifier
- D008268
- Condition
- Wet Macular Degeneration
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004683
- Subject identifier
- D057135
- Condition
- Retinal Neovascularization
- Highest recorded phase
- 4
- Condition identifier
- EFO:0005753
- Subject identifier
- D015861
- Condition
- Macular Degeneration
- Highest recorded phase
- 3
- Condition identifier
- EFO:0009606
- Subject identifier
- D008268
- Condition
- Diabetes Complications
- Highest recorded phase
- 4
- Condition identifier
- EFO:0010977
- Subject identifier
- D048909
- Condition
- Eye Diseases
- Highest recorded phase
- 1
- Condition identifier
- HP:0000478
- Subject identifier
- D005128
- Condition
- Macular Edema
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0003005
- Subject identifier
- D008269
- Condition
- Macular Edema
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0007935
- Subject identifier
- D008269
- Condition
- Choroidal Neovascularization
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0810000
- Subject identifier
- D020256
- Condition identifier
- EFO_0001365
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004683
- Condition identifier
- EFO_0005753
- Condition identifier
- EFO_0009321
- Condition identifier
- EFO_0009606
- Highest recorded phase
- 1
- Condition identifier
- EFO_0009760
- Highest recorded phase
- 2
- Condition identifier
- HP_0000478
- Condition identifier
- HP_0025569
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0001660
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0003005
- Condition identifier
- MONDO_0003005
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0004728
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005150
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005266
- Condition identifier
- MONDO_0005417
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005552
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0006951
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0007935
- Condition identifier
- MONDO_0007935
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0810000
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0810000
- Highest recorded phase
- 3
- Event
- anaemic retinopathy
- Reports
- 1
- Reporting signal score
- 7.94152
- Event
- anterior chamber cell
- Reports
- 3
- Reporting signal score
- 9.40842
- Event
- anterior chamber flare
- Reports
- 5
- Reporting signal score
- 23.7243
- Event
- anterior chamber inflammation
- Reports
- 25
- Reporting signal score
- 134.453
- Event
- bacterial endophthalmitis
- Reports
- 3
- Reporting signal score
- 15.7777
- Event
- blindness
- Reports
- 49
- Reporting signal score
- 134.171
- Event
- cerebral infarction
- Reports
- 16
- Reporting signal score
- 25.42
- Event
- chorioretinitis
- Reports
- 8
- Reporting signal score
- 35.8496
- Event
- choroidal detachment
- Reports
- 3
- Reporting signal score
- 9.8985
- Event
- choroidal haemorrhage
- Reports
- 5
- Reporting signal score
- 24.3726
- Event
- corneal endotheliitis
- Reports
- 2
- Reporting signal score
- 9.33691
- Event
- detachment of retinal pigment epithelium
- Reports
- 5
- Reporting signal score
- 16.3999
- Event
- dyspnoea
- Reports
- 2
- Reporting signal score
- 13.9132
- Event
- endophthalmitis
- Reports
- 49
- Reporting signal score
- 196.268
- Event
- eye abrasion
- Reports
- 1
- Reporting signal score
- 7.94152
- Event
- eye haemorrhage
- Reports
- 5
- Reporting signal score
- 8.12743
- Event
- eye inflammation
- Reports
- 49
- Reporting signal score
- 206.879
- Event
- eye pain
- Reports
- 18
- Reporting signal score
- 32.184
- Event
- fatigue
- Reports
- 1
- Reporting signal score
- 20.9266
- Event
- haemorrhagic occlusive retinal vasculitis
- Reports
- 2
- Reporting signal score
- 13.1127
- Event
- headache
- Reports
- 5
- Reporting signal score
- 8.57055
- Event
- hypopyon
- Reports
- 5
- Reporting signal score
- 17.1301
- Event
- idiopathic orbital inflammation
- Reports
- 2
- Reporting signal score
- 9.29966
- Event
- immune-mediated adverse reaction
- Reports
- 3
- Reporting signal score
- 9.03756
- Event
- inflammation
- Reports
- 10
- Reporting signal score
- 9.63738
And 52 more, listed on the interactive page.
- NCT01941082
- NCT02484690
- NCT03038880
- NCT04777201
- NCT05904028
- NCT03823287
- NCT03823300
- Dose
- 6 mg
- Route
- Intravitreal
- How often
- Every 4 weeks for the first 4 doses, then evaluate; possible additional 4-week dosing after initial 4 doses
- Administered by a qualified physician
- Eliminate air bubbles before administration
- Inspect visually prior to use, do not use if damaged, expired, or particulates present
- Single eye treatment per syringe or vial
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain: anti-VEGFA
- Type
- Protein
- Sequence
- EVQLVESGGGLVQPGGSLRLSCAASGYDFTHYGMNWVRQAPGKGLEWVGWINTYTGEPTYAADFKRRFTFSLDTSKSTAYLQMNSLRAEDTAVYYCAKYPYYYGTSHWYFDVWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPEAAGGPSVFLFPPKPKDTLMASRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLAQDWLNGKEYKCKVSNKALGAPIEKTISKAKGQPREPQVYTLPPCRDELTKNQVSLWCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNAYTQKSLSLSPGK
- Component
- Heavy chain: anti-ANGPT2
- Type
- Protein
- Sequence
- QVQLVQSGAEVKKPGASVKVSCKASGYTFTGYYMHWVRQAPGQGLEWMGWINPNSGGTNYAQKFQGRVTMTRDTSISTAYMELSRLRSDDTAVYYCARSPNPYYYDSSGYYYPGAFDIWGQGTMVTVSSASVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGECDKTHTCPPCPAPEAAGGPSVFLFPPKPKDTLMASRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLAQDWLNGKEYKCKVSNKALGAPIEKTISKAKGQPREPQVCTLPPSRDELTKNQVSLSCAVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLVSKLTVDKSRWQQGNVFSCSVMHEALHNAYTQKSLSLSPGK
- Component
- Glycosylation sites (N)
- Sequence
- Asn-303 $ Asn-313''''
- Component
- Glycosylation sites (N)
- Sequence
- Asn-303 $ Asn-313''
- Component
- Disulfide bridges
- Sequence
- 22'''-87''' $ 22-96 $ 22''-96'' $ 23'-88' $ 134'-194' $ 137'''-193''' $ 150-206 $ 156''-216'' $ 213'''-236' $ 214'-226 $ 232-242'' $ 235-245'' $ 267-327 $ 277''-337'' $ 360-365'' $ 373-431 $ 383''-441''
- Component
- Light chain: anti-ANGPT2
- Type
- Protein
- Sequence
- SYVLTQPPSVSVAPGQTARITCGGNNIGSKSVHWYQQKPGQAPVLVVYDDSDRPSGIPERFSGSNSGNTATLTISRVEAGDEADYYCQVWDSSSDHWVFGGGTKLTVLSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSC
- Component
- Light chain
- Type
- Protein
- Sequence
- DIQLTQSPSSLSASVGDRVTITCSASQDISNYLNWYQQKPGKAPKVLIYFTSSLHSGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQYSTVPWTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- 50242-096
Related records
Trials (52)
- A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Intravitreal OLN324
- A Proof-of-Concept Study of Faricimab (RO6867461) in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
- A Prospective Longitudinal Analysis of Faricimab (Vabysmo 6mg) For Choroidal Neovascularization in Presumed Ocular Histoplasmosis Syndrome
- A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study)
- A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products
- A Study in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety of the Faricimab Prefilled Syringe
- A Study of Faricimab (RO6867461) in Participants With Center-Involving Diabetic Macular Edema
- A Study of RO6867461 Administered in Single- and Multiple-Ascending Doses in Patients With Wet Age-Related Macular Degeneration
- A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
- A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema
- A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)
- A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion
- A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
- A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE)
- A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TENAYA)
- A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia
- A Study to Evaluate the Efficacy and Safety of IBI302 inSubjects With Diabetic Macular Edema（DME）
- A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema
- A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
- A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)
Approved for (4)
- Cystoid macular edema
- Macular retinal edema
- Ocular vascular disorder
- Wet macular degeneration
In development for (4)
- Age-related macular degeneration Phase 3
- Choroidal neovascularization Phase 2
- Eye disorder Phase 1
- Macular degeneration Phase 3