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immunoglobulin (Bivigam)

✓ Approved

ADMA Biologics, Inc. · Polyclonal Antibodies · Polyclonal Antibodies

What is immunoglobulin?

immunoglobulin is a polyclonal antibodies developed by ADMA Biologics, Inc.. It is approved for therapeutic indications via injectable (others) or intravenous (iv).

Drug Profile

Brand NamesBivigam
CompanyADMA Biologics, Inc.
Drug ClassPolyclonal Antibodies, Antibody
RouteInjectable (Others), Intravenous (IV)
StatusApproved
Sources: ClinicalTrials.gov, ADMA Biologics, Inc.

Therapeutic Indications

immunoglobulin is developed for 5 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Congenital, familial and genetic disordersCombined immunodeficiency✓ Approved
Congenital, familial and genetic disordersWiskott-Aldrich syndrome✓ Approved
Immune system disordersSelective IgG subclass deficiency✓ Approved
Congenital, familial and genetic disordersBruton's agammaglobulinaemia✓ Approved
Immune system disordersImmunodeficiency✓ Approved

Related Research Articles

PubMedExperimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation2026-10-16

High Prevalence of Oxford MEST-C Lesions in Immunoglobulin A Nephropathy of Kidney Allografts: A Single-Center Study from Viet Nam.

Thai Kinh Luan KL, La Ngoc Thu Nguyen NTN, Hoang Tien Dat TD, Duong Nguyen Xuong NX et al.

We evaluated the clinical characteristics, Oxford 2016 histopathology features, and short-term outcomes of Immunoglobulin A nephropathy in kidney transplant recipients at Cho Ray Hospital, Ho Chi Minh City, Viet Nam. This retrospective, descriptive study included kidney transplant recipients with biopsy -proven immunoglobulin A nephropathy in kidney allografts identified in 2022. We analyzed patient death with a functioning graft as a competing event and not classified as graft failure. Immunoglobulin A nephropathy was present in 27.1 % (19/70 ) of allograft biopsies. Most recipients were male (73.7 %) and received grafts from living related donors (17 /19, 89.4 % ). The mean time from transplant to immunoglobulin A nephropathy diagnosis was 5.2 years. Median follow -up after biopsy was 48 weeks. Three components of the Oxford MEST -C were frequently observed, that is, mesangial hypercellularity M1 (73.7 % ), segmental glomerulosclerosis S1 (78.9 % ), and cellular /fibrocellular crescents C1 (26.3 % ). At the end of follow -up, 68.4 % of patients maintained graft function, 15.8 % required hemodialysis, and 10.5 % died from nonrenal causes with functioning grafts. Immunoglobulin A nephropathy was frequently observed in our patient cohort; however, the inability to distinguish recurrent disease from de novo disease fundamentally limited interpretation of the histopathology patterns. Moreover, given the short -term and multifactorial nature of the outcomes, together with the limitations of the Oxford MEST -C in the allograft setting, the independent prognostic significance of these lesions remains uncertain and requires further validation through larger prospective studies.

PMID 42885704
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PubMedExperimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation2026-10-16

Hepatitis B Virus Recurrence After Liver Transplant for Hepatitis B Virus-Related Liver Disease: A Retrospective Analysis of Hepatitis B Immunoglobulin Discontinuation.

Aktuna Hakan H, Daniş Nilay N, Döngelli Hüseyin H, Bacakoğlu Aylin A et al.

Hepatitis B virus recurrence after liver transplant remains a clinically relevant issue, but the optimal duration and safety of hepatitis B immunoglobulin therapy, particularly its discontinuation, remain unclear. Here, we evaluated the incidence and risk factors of posttransplant hepatitis B virus recurrence and assessed outcomes following elective discontinuation of hepatitis B immunoglobulin in a real-world cohort. We conducted a retrospective single-center cohort study of consecutive adult patients who underwent liver transplant for hepatitis B virus-related liver disease between 1997 and 2023. Hepatitis B virus recurrence was defined as the reappearance of hepatitis B surface antigen and/or detectable hepatitis B virus DNA. We used Cox proportional hazards models to identify factors associated with recurrence and overall survival. We conducted a predefined subgroup analysis to evaluate patients who underwent elective discontinuation of hepatitis B immunoglobulin during antiviral therapy. Among 254 liver transplant recipients, 39 (15.4% ) developed posttransplant hepatitis B virus recurrence. In multivariable analysis, pretransplant hepatitis B virus DNA levels >5 log10 copies/mL (hazard ratio 3.68; 95% CI, 1.82-7.46) and hepato-cellular carcinoma at transplant (hazard ratio 2.38; 95% CI, 1.22-4.65) were independently associated with recurrence, whereas hepatitis D virus coinfection was inversely associated (hazard ratio 0.18; 95% CI, 0.08-0.43). Elective hepatitis B immunoglobulin discontinuation was not associated with increased hepatitis B virus recurrence and was primarily performed in clinically selected low-risk patients. Posttransplant hepatitis B virus recurrence was associated with reduced overall survival. In this long-term, real-world cohort, posttransplant hepatitis B virus recurrence was mainly driven by the pretransplant viral burden and oncological factors. Elective hepatitis B immunoglobulin discontinuation in carefully selected patients was not associated with increased recurrence, likely reflecting the underlying risk stratification rather than a causal protective effect. These findings support the use of individualized risk-based hepatitis B immunoglobulin strategies after liver transplant.

PMID 42885707
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PubMedmSphere2026-10-16

Characterization of the Peromyscus leucopus immunoglobulin germline repertoire and anti-OspA antibody response reveals conserved germline IGHV features among cricetid rodents.

Zhou Yu Y, Telford Sam R SR, Buchthal Joanna J, Esvelt Kevin K et al.

Peromyscus leucopus (P. leucopus) is an important reservoir host for several zoonoses, including Borrelia burgdorferi (B. burgdorferi), the causative agent of Lyme disease. However, the immunoglobulin germline repertoire underlying antibody responses in this reservoir host remains poorly defined. In this study, we characterized the immunoglobulin variable genes of P. leucopus and identified 12 IGHV, 12 IGKV, and 3 IGLV gene families comprising 129, 87, and 12 genes, respectively. These genes exhibited similar usage patterns to those of Mus musculus (M. musculus). We also identified a high-divergence region (HDR) within the germline IGHV loci of three Borrelia sp.-susceptible Cricetidae species, P. leucopus, Peromyscus maniculatus (P. maniculatus), and Arvicola amphibius (A. amphibius). Compared with the corresponding regions in Muridae species, the Cricetidae HDRs are expanded and contain a large number of IGHV genes. To investigate the antigen-specific features of the repertoire, we analyzed the antibody responses of P. leucopus to B. burgdorferi outer surface protein A (OspA), a highly immunogenic tick midgut adhesin involved in midgut colonization. Comparative analysis of more than 140 IGHV genes from immunized P. leucopus showed that germline IGHV genes encoding anti-OspA antibodies exhibited higher sequence similarity to corresponding germline IGHV genes in P. maniculatus and A. amphibius than did P. leucopus germline IGHV genes not associated with anti-OspA responses.IMPORTANCEThis study characterized the immunoglobulin gene repertoire of Peromyscus leucopus and revealed extensive diversity across its variable-region loci. Analysis of antibody response to outer surface protein A (OspA) showed that germline IGHV genes encoding anti-OspA antibodies showed higher sequence similarity to their corresponding germline IGHV genes in other Borrelia-susceptible cricetid rodents, suggesting that conserved germline IGHV features are associated with OspA recognition. These findings lay the foundation for further understanding of antibody responses in this important reservoir host.

PMID 42885934
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PubMedCancers2026-10-16

Immunoglobulin A Subtype and Survival After Upfront Autologous Stem Cell Transplantation in Multiple Myeloma: A Real-World Cohort from the Bortezomib Era.

Güllü Koca Tuba T, Koca Nizameddin N, Hunutlu Fazıl Çağrı FÇ, Yanık Ahmet Mert AM et al.

Immunoglobulin isotype is recorded at diagnosis in every patient with intact-immunoglobulin multiple myeloma, but is not retained in the ISS, R-ISS, or R2-ISS. We analyzed 196 consecutive patients with IgA or IgG myeloma who underwent upfront autologous stem cell transplantation at a single center (2009-2023). The primary endpoint was progression-free survival (PFS); overall survival (OS) was the secondary endpoint. Cox models used information available at transplantation, including the induction regimen and transplant year, in the complete-case set (n = 131) and after multiple imputation (n = 196). Median PFS was 14.8 versus 30.5 months and OS 43.2 versus 94.2 months in IgA versus IgG patients (both p < 0.001). IgA isotype was associated with inferior PFS (adjusted HR 1.85, 95% CI 1.13-3.02; imputed HR 1.83, 95% CI 1.22-2.73). For OS, the HR was 1.68 (0.98-2.88) in the complete-case analysis and 1.91 (1.24-2.94) after imputation, so its magnitude is uncertain. Models with maintenance gave 1.87 and 1.82. Progression documentation differed by maintenance status. Cytogenetic data were too incomplete to assess independence from genomic risk. In a bortezomib-era transplant cohort, IgA isotype was associated with inferior PFS; the association with OS was of uncertain magnitude. The finding is hypothesis-generating and requires validation in cohorts with complete cytogenetic characterization.

PMID 42882872
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PubMedJournal of Alzheimer's disease : JAD2026-10-16

Immunoglobulin GM (γ marker) allotypes as potential genetic markers of efficacy of lecanemab therapy in Alzheimer's disease.

Pandey Janardan P JP

Lecanemab is a humanized IgG1 monoclonal antibody that targets amyloid-β (Aβ) aggregates, a pathological hallmark of Alzheimer's disease (AD). In the largest clinical trial of its kind to date, lecanemab slowed cognitive decline by 27% in patients with early-stage AD. Lecanemab has also been shown to reduce cerebral Aβ deposition. Lecanemab expresses the immunoglobulin GM 3 allotype, which is defined by an arginine residue in the CH1 region of the γ1 chain and is potentially immunogenic in individuals who lack this allotype. I hypothesize that anti-GM 3 antibodies, generated either following lecanemab administration or acquired previously through maternal-fetal incompatibility or transfusion of allotype-incompatible blood products, may form immune complexes with the therapeutic antibody. These immune complexes could be cleared by phagocytic cells, including microglia, thereby reducing the availability and efficacy of lecanemab and contributing to therapeutic nonresponsiveness. If validated, GM allotypes could serve as genetic markers for predicting response to lecanemab therapy and may help guide personalized treatment strategies in AD.

PMID 42885677
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PubMedCells2026-10-16

The Role of the Immunoglobulin Superfamily of Cell Adhesion Molecules in Intellectual Disability.

Zaman Nishat N, Bui Karina K, Sytnyk Vladimir V

Immunoglobulin superfamily (IgSF) cell adhesion molecules (CAMs) are cell surface glycoproteins that play critical roles during multiple stages of synapse formation, including axon and dendrite growth and guidance, target recognition, axo-dendritic contact formation and its maturation into a functional synapse. Intellectual disability is a condition characterized by significant limitations in intellectual functioning and adaptive behaviors. Growing evidence indicates that deficits in synapse formation underlie the pathogenesis of intellectual disability. In this review, we discuss studies showing that levels and functions of IgSF CAMs are affected in various syndromes and disorders associated with intellectual disability, including Fragile X syndrome, Rett syndrome, Down syndrome, autism spectrum disorder, L1 syndrome and fetal alcohol spectrum disorders. We highlight functional studies in cellular and animal models showing that changes in levels and functions of IgSF CAMs impair synapse formation and induce learning and behavioral abnormalities resembling those found in people with intellectual disability. Together, these studies indicate that IgSF CAMs need to be considered as important therapeutic targets for treating intellectual disability and their functions need to be assessed when new treatments of this condition are developed.

PMID 42882499
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