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roledumab
- Development stage
- Phase 2
- Lead developer
- LFB
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
- Administration
- Intravenous, Intramuscular
01
Overview
Roledumab is a fully human recombinant IgG1 monoclonal antibody that targets the Rhesus D (RhD) antigen on red blood cells. It is designed for the prevention of fetomaternal alloimmunization in RhD-negative pregnant women carrying an RhD-positive fetus. Roledumab binds specifically to the RhD epitope (not present on certain rare variants such as DVI, DFR, DHAR and DHMI), leading to immune-mediated clearance of fetal RhD-positive red blood cells from maternal circulation. Compared to polyclonal anti-D immunoglobulin products traditionally used for this indication, roledumab demonstrates increased affinity for FcγRIIIa due to low Fc-fucosylation and enhanced antibody-dependent cellular cytotoxicity (ADCC) by natural killer cells. Its pharmacokinetic profile and safety are similar to those of polyclonal anti-D[1][3][5][6].
- Brand names
- Dmatria
- Other names
- Anti-D monoclonal antibodyAnti-RhD-antibodyAnti-Rhesus-D-monoclonal-antibody-LFBMonoclonal-anti-D
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