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Imlifidase

Kidney transplantation in highly sensitized patients

Manufacturer
Hansa Biopharma
Regulatory submission
BLA submitted December 2025
85 sources

Section 1 of 6

Terms and abbreviations

1 evidence topic · 0 sources

AbbreviationTerm
ABMRAntibody-mediated rejection
ADCCAntibody-dependent cell-mediated cytotoxicity
AHFSAmerican Hospital Formulary Service
AMAcceptable mismatch
AMRAntibody-mediated rejection
ATCAnatomical Therapeutic Chemical classification
BLABiologics License Application
CAVClinical added value
CDCComplement-dependent cytotoxicity
CIConfidence interval
CKDChronic kidney disease
cPRA/CPRACalculated panel-reactive antibody
DSADonor-specific antibody
eGFREstimated glomerular filtration rate
EMAEuropean Medicines Agency
ESRDEnd-stage renal disease
EUEuropean Union
F(ab′)2Bivalent antigen-binding antibody fragment
FcFragment crystallizable region of an antibody
FDAFood and Drug Administration
HLAHuman leukocyte antigen
HRQoLHealth-related quality of life
HSEHealth Service Executive
ICERIncremental cost-effectiveness ratio
IdeSImmunoglobulin G-degrading enzyme of Streptococcus pyogenes
IFEImmunofixation electrophoresis
IgGImmunoglobulin G
ISEImmunosubtraction electrophoresis
ITTIntention to treat
IVIntravenous
IVIG/IVIgIntravenous immunoglobulin
KASKidney Allocation System
KEPKidney exchange program
LDKTLiving donor kidney transplantation
MENAMiddle East and North Africa
MFIMean fluorescence intensity
MICAMajor histocompatibility complex class I chain-related protein A
NCPENational Centre for Pharmacoeconomics
NCTClinicalTrials.gov study identifier prefix
NHSNational Health Service
NKNatural killer
PAESPost-authorization efficacy study
PASPatient Access Scheme
PDUFAPrescription Drug User Fee Act
PEX/PLEXPlasma exchange
PRAPanel-reactive antibody
QALYQuality-adjusted life-year
rATGRabbit anti-thymocyte globulin
RMPRisk management plan
SABSingle-antigen bead
ScIgGSingle-cleaved immunoglobulin G
SmPCSummary of Product Characteristics
SoCStandard of care
SPESerum protein electrophoresis
TEAETreatment-emergent adverse event
TRTransplant rate
TTPThrombotic thrombocytopenic purpura
VATValue-added tax