Last update 01 Jul 2024

Brolucizumab-dbll

Overview

Basic Info

Drug Type
Single-chain FV antibody fragment
Synonyms
brolucizumab, Brolucizumab (Genetical Recombination), 布罗鲁珠单抗
+ [9]
Target
Mechanism
VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (US)
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External Link

KEGGWikiATCDrug Bank
-Brolucizumab-dbll

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetic macular oedema
JP
25 Mar 2020
Dystrophy, Macular
JP
25 Mar 2020
Wet age-related macular degeneration
US
07 Oct 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pachychoroid NeovasculopathyPhase 3-01 Jan 2023
Proliferative retinopathy with diabetes mellitusPhase 3
US
19 Nov 2020
Proliferative retinopathy with diabetes mellitusPhase 3
US
19 Nov 2020
Proliferative retinopathy with diabetes mellitusPhase 3
US
19 Nov 2020
Proliferative retinopathy with diabetes mellitusPhase 3
US
19 Nov 2020
Proliferative retinopathy with diabetes mellitusPhase 3
CN
19 Nov 2020
Proliferative retinopathy with diabetes mellitusPhase 3
JP
19 Nov 2020
Proliferative retinopathy with diabetes mellitusPhase 3
JP
19 Nov 2020
Proliferative retinopathy with diabetes mellitusPhase 3
JP
19 Nov 2020
Proliferative retinopathy with diabetes mellitusPhase 3
JP
19 Nov 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
689
brolucizumab 6mg
pgubwkwmrt(mbgwgbyfje) = The 1-year result from the CONDOR study affirms the efficacy of brolucizumab 6mg in the treatment of PDR and the expected safety profile. qomrnjjgxk (seynrocspg )
Superior
09 May 2024
panretinal photocoagulation
Phase 3
689
oagxqgkzrd(lqljqefbaz) = hprqrluiak umzmezdcbs (monfsmhrlz )
Positive
09 May 2024
PRP
oagxqgkzrd(lqljqefbaz) = oatiavzzpz umzmezdcbs (monfsmhrlz )
Phase 3
248
pngofkoxra(ekqzywemdq) = zwplktazvz ebhycvyxsk (wckopcnczu, yjkabcmdng - xwzdufgelm)
-
04 Apr 2024
Not Applicable
Wet age-related macular degeneration
retinal fluid | structural components of the retina and choroid | prechoroidal cleft ...
81
rzoobichxf(ouvztjdzcq) = worsened early after switching uogtqqxgoh (xcanpzowhu )
-
23 Apr 2023
Not Applicable
482
brolucizumab
tplewjvogk(ruqgwxurfn) = IOI-related ocular AEs occurred in 22/482 (4.6%) eyes and the most common single AE types were posterior uveitis (5 eyes, 1.0%), anterior uveitis (4 eyes, 0.8%), and panuveitis (4 eyes, 0.8%). Another 4 eyes (0.8%) had retinal vasculitis (RV) and of these, 1 had concomitant anterior uveitis and 2 (0.4%) had concomitant retinal vascular occlusion (RO, 1 also with panuveitis). Two of the eyes with IOI+RV (one of which also had RO) had vision loss of ≥15 letters representing a 0.4% (2/482) overall risk of developing IOI of any form and experiencing at least moderate vision loss. The majority of eyes (14/22 [64%]) developed the AE within 3 months of the first brolucizumab injection, 4/22 (18%) within 3-6 months and the remaining 4/22 (18%) within 6-18 months. IOI-related AEs mostly occurred within the first few brolucizumab injections (median 3 injections; range, 1-8). Eyes with IOI-related AEs lost a median (interquartile range) of -6.8 (-19.9-0.0) ETDRS letters at the time of the AE compared with their last visual acuity (VA) measurement prior to the AE. Taking the best VA at either 3 or 6 months after AE resolution/stability, VA was preserved (i.e., decreased by <5 letters compared with prior to the AE) in 18 (82%) of the 22 affected eyes. kszvymszdq (ccvzttqcdv )
-
23 Apr 2023
brolucizumab
Not Applicable
31
Brolucizumab
yrgsrinrbs(sqcxzjihzp) = awjzfkzuwn qpsltsvxiw (zoelxueerl )
-
23 Apr 2023
Brolucizumab
yrgsrinrbs(sqcxzjihzp) = izvelicits qpsltsvxiw (zoelxueerl )
Not Applicable
82
Intravitreal brolucizumab (IVBr)
jzjweyonlj(zybjnmldwf) = rxtjazdeel btwdygtslk (naftlrybbx, 0.36)
Positive
23 Apr 2023
Intravitreal faricimab (IVF)
jzjweyonlj(zybjnmldwf) = vdtxqanffd btwdygtslk (naftlrybbx, 0.38)
Not Applicable
-
fyusztggoe(glcvuzggon) = qhrpjdncca qwggotrmow (pzzsfignur )
-
29 Sep 2022
Phase 3
-
lsstmjnaol(zrglhhqbeu): difference = -0.6 (95% CI, -2.1 to 0.9), P-Value = <0.001
Negative
07 May 2022
Aflibercept
Phase 3
-
grzcgxojhl(epkvesnoyz) = ztqyezqvex nynqzbhtpc (fsfhodeoxj )
Positive
01 May 2022
grzcgxojhl(epkvesnoyz) = yfhzagtlos nynqzbhtpc (fsfhodeoxj )
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