MedPath

Human immunoglobulin G

Generic Name
Human immunoglobulin G
Brand Names
Asceniv, Bivigam, Cuvitru, Flebogamma, Gamastan, Gammagard, Gammaked, Gammaplex, Gamunex, Hizentra, Hyqvia 5 G / 50 Ml Kit, Igivnex, Kiovig, Octagam, Panzyga, Privigen, Xembify, HyQvia, Flebogamma DIF (previously Flebogammadif)
Drug Type
Biotech
CAS Number
308067-58-5
Unique Ingredient Identifier
66Y330CJHS
Background

Intravenous immunoglobulin (IVIg) is a mixture of IgG1 and other antibodies derived from healthy human plasma via Cohn fractionation. The purification process includes cold alcohol fractionation, polyethylene glycol precipitation, and ion exchange chromatography. IVIg contains the same distribution of IgG antibody subclasses as is found in the general human population. IgG subclasses are fully represented in the following proportions: 70.3% IgG1, 24.7% IgG2, 3.1% IgG3, and 1.9% IgG4. IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders.

Indication

Human immunoglobulin G is indicated for the following conditions:

Associated Conditions
Acute Idiopathic Thrombocytopenic Purpura, Bacterial Infections, Chronic Idiopathic Thrombocytopenic Purpura, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Coronary Artery Aneurysm, Dermatomyositis (DM), Hepatitis A, Measles, Multifocal Motor Neuropathy (MMN), Primary humoral immunodeficiency, Rubella, Secondary humoral immunodeficiency, Varicella
Associated Therapies
Maintenance therapy

Riliprubart Shows Promise in CIDP Treatment with Significant Neurofilament Light Reduction

• Phase 2 study results reveal that Sanofi's investigational riliprubart reduced plasma neurofilament light levels by 31% in patients with chronic inflammatory demyelinating polyneuropathy. • Greater reductions in neurofilament light levels correlated with higher treatment response rates, with up to 69% of patients showing improvement in disability scores. • Riliprubart, a selective inhibitor of the classical complement pathway, is now being evaluated in two global Phase 3 trials (MOBILIZE and VITALIZE) across 28 countries.

Global Thrombocytopenia Clinical Trials Market Sees Significant Growth in 2025

• The global thrombocytopenia clinical trials landscape is expanding rapidly with over 25 pharmaceutical companies developing 25+ treatment therapies, according to recent market analysis. • Key industry players including GSK, Novartis, Amgen, and Sanofi are leading clinical development efforts, with several promising candidates in late-stage trials showing efficacy in reducing thrombocytopenia events. • Recent advances include Takeda's TAK-755 demonstrating 60% reduction in thrombocytopenia events compared to standard of care, and HUTCHMED completing enrollment for its pivotal Phase III ESLIM-01 trial of sovleplenib for immune thrombocytopenia.

FDA Approves ADMA Biologics' Innovative Yield Enhancement Process for Immune Globulin Production

• ADMA Biologics has received FDA approval for a groundbreaking production process that increases immune globulin yields by approximately 20% from the same plasma volume, becoming the first U.S. company to achieve this regulatory milestone. • The yield enhancement technology will benefit both ASCENIV and BIVIGAM product lines, substantially increasing production capacity and supporting revenue growth beginning in late 2025 with further acceleration expected through 2026. • This innovation represents a significant advancement in plasma fractionation efficiency, potentially expanding access to immune globulin treatments for immunocompromised patients while improving the company's profit margins.

Biotest Reports 6% Sales Growth in 2024, FDA Approves Yimmugo for US Market

• Biotest AG achieved €726.2 million in sales for 2024, a 6.1% increase driven primarily by strong performance of Intratect and Yimmugo, with EBIT reaching €94.5 million at the upper end of forecast range. • The FDA approved Yimmugo in June 2024 and certified Biotest's production facility, enabling the company to secure a long-term distribution agreement with Kedrion Biopharma expected to generate over $1 billion in the next seven years. • Biotest successfully completed the AdFirst Phase III trial and submitted marketing authorization applications for its new fibrinogen preparation in key European markets and to the FDA, with approval decisions expected by the end of 2025.

Health Canada Expands HyQvia Authorization for CIDP Maintenance Therapy

• Health Canada has expanded marketing authorization for Takeda's HyQvia as a maintenance therapy for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults after stabilization with intravenous immunoglobulin. • HyQvia is now the only subcutaneous immunoglobulin treatment in Canada that can be administered as infrequently as once monthly and can be self-administered at home after proper training, reducing hospital visits. • The approval is based on the Phase 3 ADVANCE-1 trial, which demonstrated a significant reduction in CIDP relapse rates with HyQvia compared to placebo (15.5% vs 31.7%), with an estimated treatment difference of -16.2%.

Grifols' Immunoglobulin Therapy Shows Promising Results in Post-Polio Syndrome Clinical Trial

• A one-year clinical trial of Grifols' intravenous immunoglobulin therapy Flebogamma 5% DIF demonstrated significant mobility improvements in post-polio syndrome patients, with treated participants walking 12.75 meters farther in the two-minute walk test. • The phase 2/3 study involving 191 participants met its primary endpoint, showing the treatment can halt and even reverse the previously considered inevitable physical decline associated with post-polio syndrome. • Post-polio syndrome affects 25-40% of polio survivors years after initial infection, with an estimated 12-20 million survivors worldwide at risk, and until now, treatment options were limited to symptom management.

Hansa Biopharma Completes Enrollment in Phase 3 Study of Imlifidase for Highly Sensitized Kidney Transplant Patients

• Hansa Biopharma has completed enrollment in its European Phase 3 PAES study evaluating imlifidase (IDEFIRIX®) in highly sensitized kidney transplant patients, with data readout expected in the second half of 2026. • The study includes 50 highly sensitized kidney transplant patients who received imlifidase desensitization treatment and 64 patients in a reference cohort, spanning 22 European clinical sites. • Imlifidase works by cleaving immunoglobulin G antibodies, creating a window of opportunity for HLA-incompatible kidney transplantation in patients who might otherwise face indefinite waiting times for compatible organs.

RSV Treatment Landscape Expands with New Vaccines and Clinical Trials in 2024-2025

• Moderna's mRESVIA vaccine received MHRA approval in February 2025 for adults aged 60 and older, joining GSK's Arexvy and Pfizer's Abrysvo in the expanding RSV vaccine market. • The FDA has mandated new safety warnings for RSV vaccines regarding Guillain-Barré Syndrome risk, highlighting ongoing safety monitoring efforts in early 2025. • Multiple pharmaceutical companies including Sanofi, GSK, and Pfizer are conducting advanced clinical trials in 2024, focusing on various patient populations and novel therapeutic approaches.

Biomerica's inFoods IBS Test Shows Significant Pain Reduction in Clinical Trial, Particularly Effective for IBS-C and IBS-M Patients

• Clinical trial results reveal inFoods IBS test achieved 59.6% success rate in reducing abdominal pain through targeted food elimination, compared to 42.2% in control group. • The test demonstrated exceptional efficacy in IBS-C and IBS-M subtypes, with 67.1% and 66% of patients respectively meeting FDA pain reduction targets. • Novel IBS-specific IgG antibody test enables precision nutrition approach by identifying individual trigger foods, requiring elimination of only 2-4 foods on average.

Alumis and Acelyrin Announce Merger to Create $737M Clinical-Stage Biopharma Company

• Alumis and Acelyrin have agreed to merge in an all-stock transaction, creating a combined entity with $737 million in cash runway extending into 2027. • The merged company will retain the Alumis name and prioritize development of two TYK2 inhibitors targeting conditions including psoriasis, lupus, and multiple sclerosis. • Acelyrin's thyroid eye disease drug lonigutamab is included in the deal but will undergo strategic review to assess its market differentiation potential.

EMA Recommends Approval for New Cancer Treatments and Vaccines

• The European Medicines Agency (EMA) has recommended eight new products for EU-wide approval, expanding treatment options for various conditions. • Several cancer treatments have received positive recommendations, potentially offering new hope for patients with different types of malignancies. • A new antiparasitic combination has been endorsed for use in non-EU markets, addressing a critical need in regions affected by parasitic infections. • The EMA is also reviewing new safety information regarding Leqembi, an Alzheimer's disease treatment, ensuring ongoing monitoring of its benefit-risk profile.

Adaptive Biotechnologies Reports Strong MRD Business Growth in 2024 Financial Results

• Adaptive Biotechnologies reported 42% growth in its Minimal Residual Disease (MRD) business for 2024, with clonoSEQ test volume increasing 35% to 76,105 tests delivered throughout the year. • The company secured a 17% increase in Medicare reimbursement rates for clonoSEQ tests and expanded Medicare coverage to include Mantle Cell Lymphoma, enabling new promotional efforts. • Despite overall revenue growth of 5% to $179 million in 2024, Adaptive reduced its net loss to $159.6 million from $225.3 million in 2023, with a focus on achieving MRD profitability in 2025.

Nipocalimab Receives FDA Priority Review for Generalized Myasthenia Gravis Treatment

• The FDA granted Priority Review to nipocalimab for treating gMG in antibody-positive patients, expediting its potential availability to patients. • Phase 3 Vivacity-MG3 study results supported the application, demonstrating sustained disease control and significant MG-ADL score reduction. • Nipocalimab, a monoclonal antibody, aims to reduce IgG autoantibodies, addressing the underlying cause of gMG without broad immunosuppression. • Johnson & Johnson also submitted a Marketing Authorisation Application to the EMA, seeking approval of nipocalimab in gMG in Europe.

Takeda's HYQVIA Approved in Japan for Agammaglobulinemia and Hypogammaglobulinemia

• Japan's MHLW has approved Takeda's HYQVIA for treating agammaglobulinemia and hypogammaglobulinemia, conditions marked by low antibody levels. • HYQVIA is the first facilitated subcutaneous immunoglobulin therapy available in Japan, offering less frequent dosing. • The approval is based on Phase III trials in Japanese and North American patients, demonstrating efficacy and manageable side effects. • HYQVIA provides a reduced dosing frequency of every three to four weeks, compared to weekly or bi-weekly dosing schedules.

VYVDURA Approved in Japan for Chronic Inflammatory Demyelinating Polyneuropathy

• Japan's MHLW has approved VYVDURA (efgartigimod alfa and hyaluronidase-qvfc) for treating adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). • VYVDURA is the first and only neonatal Fc receptor (FcRn) blocker approved for CIDP treatment, administered as a weekly subcutaneous injection. • The approval is based on the ADHERE study, which demonstrated a 61% reduction in relapse risk compared to placebo (p<0.0001) and clinical improvement in 69% of patients. • This approval expands treatment options for CIDP patients in Japan, offering a convenient at-home self-injection alternative.

Study Calls for Optimization of High-Cost IVIG Therapy in BK Nephropathy Treatment

• Research from the Medical University of South Carolina indicates that single-dose IVIG therapy (2g/kg) may be sufficient for clearing BK viral load in nephropathy patients, potentially reducing overall treatment costs. • Pharmacists play a crucial role in collaborating with healthcare providers to ensure appropriate patient selection and optimal use of high-cost IVIG therapy in BK nephropathy cases. • Future large-scale studies are needed to identify ideal candidates for IVIG therapy and compare its effectiveness against standard care in BK nephropathy treatment.

Ruxoprubart Receives FDA IND Clearance for Phase II Trials in IgAN and Dermatomyositis

• NovelMed's Ruxoprubart, a selective alternative complement pathway inhibitor, has received FDA IND clearance for a Phase II efficacy trial in Immunoglobulin A Nephropathy (IgAN). • Ruxoprubart also received FDA IND clearance for a Phase II trial for Dermatomyositis (DM), a rare autoimmune disorder affecting the skin and muscles. • Ruxoprubart uniquely spares the classical complement pathway, potentially offering a safer profile compared to existing complement blockers that may carry Black Box Warnings. • Clinical data from Phase I and II trials in PNH patients showed promising safety and efficacy, supporting Ruxoprubart's potential across multiple complement-mediated diseases.

FDA Wraps Up 2024 with Key Approvals for Drugs Targeting Various Conditions

• The FDA approved Vertex's Alyftrek for cystic fibrosis, offering improved dosing and potential market exclusivity. • Novo Nordisk's Alhemo was approved for hemophilia A and B, providing a new option for patients with inhibitors. • Bristol Myers Squibb's Opdivo Qvantig gained approval as a subcutaneous formulation, offering faster administration for various solid tumors. • Eli Lilly's Zepbound secured approval for obstructive sleep apnea in obese adults, marking the first prescription medicine for this condition.

FDA Approves Rystiggo (rozanolixizumab-noli) for Generalized Myasthenia Gravis

• The FDA has approved Rystiggo (rozanolixizumab-noli) for treating generalized myasthenia gravis (gMG) in adults with specific antibody-positive subtypes. • Rystiggo, a humanized IgG4 monoclonal antibody, reduces circulating IgG levels by binding to the neonatal Fc receptor (FcRN). • Clinical trials demonstrated statistically significant improvements in MG-ADL and QMG scores with Rystiggo compared to placebo. • The most common adverse reactions reported were headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.
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