Gamunex (intravenous normal human immunoglobulin 10%) / Bayer, Grifols, Kedrion - LARVOL DELTA

Intravenous Gammaglobulin for Sickle Cell Pain Crises (clinicaltrials.gov) - P1/2 | N=300 | Completed | Sponsor: Albert Einstein College of Medicine | Recruiting ➔ Completed | Trial completion date: Dec 2026 ➔ Dec 2024 | Trial primary completion date: Dec 2026 ➔ Dec 2024

Trial completion • Trial completion date • Trial primary completion date • Genetic Disorders • Hematological Disorders • Pain • Sickle Cell Disease

A Paradoxal Reaction from Intravenous Immunoglobulin (ASH 2023) - "She received 1000 mg of IV methylprednisolone and 2 grams per kilogram of IVIG (Gamunex) to manage her presenting symptoms. While our patient had no complications from the developed thrombocytopenia, subsequent infusions will be needed for her inevitable CIDP flares. Closer observation and frequent lab draws will be needed to mitigate any future IVIG-associated thrombocytopenia."

Anemia • Back Pain • Cardiovascular • CNS Disorders • Fatigue • Hematological Disorders • Hepatitis B • Hepatitis C • Hepatology • Immunology • Infectious Disease • Inflammation • Musculoskeletal Pain • Myocardial Infarction • Pain • Thrombocytopenia • Thrombosis

Pharmacokinetics of a New Intravenous Immunoglobulin (IVIg) 10% (KIg10) in Primary Immunodeficiency (PI) Patients (CIS 2025) - P3 | "In study KIG10_US3_PID01, measured PK parameters for KIg10 in adult patients with PID were considered comparable with previously published data for other IVIg treatments. Table 1. Baseline-corrected PK Parameter KIg10 Dosing Schedule 21-day (N = 5) 28-day (N = 18) C max (mg/dL), mean (SD) 1510 (12.1) 1210 (33.8) T 1/2 (hours), mean (SD) 107 (45.5) 158 (48.4) AUC 0-t (day*mg/dL), mean (SD) 8250 (20.0) 8870 (34.7) C max = maximum observed concentration; T 1/2 = terminal half-life; AUC 0-t = area under the concentration-time curve from time 0 to time t of the last quantifiable concentration."

Clinical • PK/PD data • Immunology • Infectious Disease • Influenza • Pneumococcal Infections • Primary Immunodeficiency • Respiratory Diseases • Tetanus

Safety and Tolerability of a New Intravenous Immunoglobulin (IVIg) 10% (KIg10) in Primary Immunodeficiency (PI) Adult Patients (CIS 2025) - P3 | "In study KIG10_US3_PID01, KIg10 showed a favorable safety profile and was well tolerated in adult patients with PI at the dosing schedules and infusion rates used."

Clinical • Fatigue • Hematological Disorders • Immunology • Otorhinolaryngology • Pain • Primary Immunodeficiency • Respiratory Diseases • Sinusitis

SYMMETRICAL DRUG-RELATED INTERTRIGINOUS AND FLEXURAL EXANTHEMA (SDRIFE) FOLLOWING FIRST ADMINISTRATION OF IMMUNOGLOBULIN REPLACEMENT (ACAAI 2024) - "Case Description: A 34-year-old female with history of multiple sclerosis on rituximab therapy was initially evaluated for hypogammaglobulinemia with recurrent upper respiratory infections. Workup revealed decreased immunoglobulin G (IgG) of 466 mg/dl, absent titers to streptococcus pneumoniae and haemophilus influenza without improvement following Pneumovax challenge...Emergency room evaluation with Dermatology evaluation revealed normal blood counts and chemistries with elevated C-reactive protein suggestive of a diagnosis of SDRIFE that was treated with a prednisone taper...This case describes the second reported SDRIFE resulting from IVIG and is the first to describe successful avoidance of exanthem on subsequent exposures. With the change to Gamunex from Privigen formulation, the patient has tolerated the recommended treatment without further complications and remains infection free."

CNS Disorders • Dermatology • Infectious Disease • Influenza • Multiple Sclerosis • Pneumococcal Infections • Pneumonia • Respiratory Diseases • CRP

Intravenous Gammaglobulin for Sickle Cell Pain Crises (clinicaltrials.gov) - P1/2 | N=300 | Recruiting | Sponsor: Deepa Manwani | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Genetic Disorders • Hematological Disorders • Pain • Sickle Cell Disease

Intravenous Gammaglobulin for Sickle Cell Pain Crises (clinicaltrials.gov) - P1/2 | N=300 | Recruiting | Sponsor: Deepa Manwani | Trial completion date: Sep 2024 ➔ Dec 2025 | Trial primary completion date: Sep 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Genetic Disorders • Hematological Disorders • Pain • Sickle Cell Disease

Intravenous Gammaglobulin for Sickle Cell Pain Crises (clinicaltrials.gov) - P1/2 | N=300 | Recruiting | Sponsor: Albert Einstein College of Medicine | N=94 ➔ 300 | Trial completion date: Jul 2025 ➔ Sep 2024

Enrollment change • Trial completion date • Genetic Disorders • Hematological Disorders • Pain • Sickle Cell Disease

Retrospective Study on Vaccine Responses and Natural Course of COVID-19 Infections in Primary Immunodeficiency (CIS 2023) - "Two of them tested positive for nucleocapsid and spike antibodies in high titers and they were receiving Gammagard or Gamunex infusions, suggesting that these immunoglobulin preparations contain COVID-19 antibodies. We are still in the process of analyzing our data to see if diagnosis, IgG preparations, date of testing, B cell numbers, and drugs play a role in producing nucleocapsid antibodies and high spike antibody titers."

Retrospective data • Developmental Disorders • Genetic Disorders • Immunology • Infectious Disease • Novel Coronavirus Disease • Primary Immunodeficiency • Respiratory Diseases • Solid Tumor • Thymoma • Thymus Cancer

Fatigue, depression, and product tolerability during long-term treatment with intravenous immunoglobulin (Gamunex® 10%) in patients with chronic inflammatory demyelinating polyneuropathy. (PubMed, BMC Neurol) - "Long-term treatment of CIDP patients with IVIG 10% in real-world conditions maintained clinical stability on fatigue and depression over 96 weeks. This treatment was well-tolerated and safe."

Journal • CNS Disorders • Depression • Fatigue • Mood Disorders • Pain • Psychiatry

Reply to: Intravenous immunoglobulin (Gamunex® 10%) is licensed for the treatment of severe acute exacerbations of myasthenia gravis. (PubMed, Expert Opin Pharmacother) - No abstract available

Journal • CNS Disorders • Myasthenia Gravis

Intravenous immunoglobulin (Gamunex® 10%) is licensed for the treatment of severe acute exacerbations of myasthenia gravis. (PubMed, Expert Opin Pharmacother) - No abstract available

Journal • CNS Disorders • Myasthenia Gravis

A Budget Impact Model of Maintenance Treatment of Chronic Inflammatory Demyelinating Polyneuropathy with IgPro20 (Hizentra) Relative to Intravenous Immunoglobulin in the United States. (PubMed, Pharmacoecon Open) - "This analysis projects that Hizentra is likely associated with favorable economic benefit compared with IVIG in managing CIDP."

HEOR • Journal • Immune Modulation • Immunology • Inflammation • Pain

Intravenous Gammaglobulin for Sickle Cell Pain Crises (clinicaltrials.gov) - P1/2 | N=94 | Recruiting | Sponsor: Albert Einstein College of Medicine | Trial completion date: Jul 2024 ➔ Jul 2025 | Trial primary completion date: Sep 2023 ➔ Sep 2024

Trial completion date • Trial primary completion date • Genetic Disorders • Hematological Disorders • Pain • Sickle Cell Disease

Intravenous Gammaglobulin for Sickle Cell Pain Crises (clinicaltrials.gov) - P1/2 | N=94 | Recruiting | Sponsor: Albert Einstein College of Medicine | Trial completion date: Jul 2023 ➔ Jul 2024 | Trial primary completion date: Sep 2022 ➔ Sep 2023

Trial completion date • Trial primary completion date • Genetic Disorders • Hematological Disorders • Pain • Sickle Cell Disease

Now You See It, Now You Don’t: A Case of Transient Passage of Hepatitis B Core Antibody After Infusion of Intravenous Immunoglobulin (ACG 2021) - "Case Description/ A 76 year-old woman with stiff-person syndrome was treated with intravenous immunoglobulin therapy (Gamunex 60 grams every 6 weeks) from 2015 to 2019...She was started on entecavir...The pooling of plasma from 3,000-10,000 donors to create IVIG can lead to passive transfer of transient antibodies that wane with the 21-day half-life of IVIG. In the setting of increasing use of both IVIG and rituximab, this case serves to increase awareness of this phenomenon and to prevent confusion that can lead to unnecessary treatment of HBV, delays in starting rituximab, and needless anxiety for patients."

Clinical • CNS Disorders • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Liver Failure • Mood Disorders • Psychiatry

In vitro comparison between different 10% intravenous immunoglobulin preparations (DGHO 2021) - "Material and Purity profile and biological characteristics of IqY mune® were compared to other marketed 10% IVIg (Privigen®, Octagam®, Gamunex®, and Kiovig®). Although different IVIg preparations essentially consist of polyclonal IgG, the different purification processes lead to variations in other characteristics. The IqYmune manufacturing process developed with a QbD approach has generated a 10% IVIg having a higher level of quality and enhanced safety profile while maintaining a high level of efficacy."

Preclinical • Hypotension

The Ability of Zika virus Intravenous Immunoglobulin to Protect From or Enhance Zika Virus Disease. (PubMed, Front Immunol) - "Three IVIGs (ZIKV-IG, Control-Ig and Gamunex) were evaluated for their ability to neutralize and/or enhance Zika, dengue 2 and 3 viruses in vitro. Using this approach, we were able to define the unique in vivo dynamics of complex polyclonal antibodies, allowing for both enhancement and protection from flavivirus infection. Our results provide a novel understanding of how polyclonal antibodies interact with viruses with implications for the use of polyclonal antibody therapeutics and the development and evaluation of the next generation flavivirus vaccines."

Journal • Dengue Fever • Infectious Disease

Intravenous Immunoglobulins in Complex-regional Pain Syndrome (clinicaltrials.gov) - P3; N=0; Withdrawn; Sponsor: University of Giessen; N=36 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Musculoskeletal Pain • Pain

Post IVIG Medication in Children With Immune Thrombocytopenia (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: Baylor College of Medicine

Adverse events • Clinical • New P1 trial • Hematological Disorders • Thrombocytopenia • Thrombocytopenic Purpura

[VIRTUAL] Industry poster: An observational study to assess individualized Gamunex® 10% treatment decisions in patients with Chronic Immune-mediated Neuropathies: Study design and progress (DGN 2020) - No abstract available

Clinical • Observational data

Grifols to Acquire GC Pharma’s Plasma Facilities for $460M (Contract Pharma) - "Grifols...has entered an agreement to acquire GC Pharma Group’s Montreal-based plasma fractionation facility and two purification facilities, along with 11 U.S.-based plasma collection centers for $460 million....Grifols plans to be ready to manufacture IVIG and Albumin in the facilities to supply the Canadian market starting in 2023. As part of the transaction, Grifols has also committed to supplying certain output of plasma arising out of the Green Cross Collection Centers to GC Pharma (Group) for a 24-month period."

M&A

Occurrence of acute renal failure on the same day as immune globulin product administrations during 2008 to 2014. (PubMed, Transfusion) - "The study showed variation in the risk of IG-related ARF by age, sex, and IG products. The study results suggest the importance of recipient factors, such as older age and underlying health conditions. Variations in ARF occurrence may also be explained by product dosage, administration route and rate, and manufacturing processes, which warrant further evaluation."

Journal • Biosimilar • Cardiovascular • Renal Disease

iSTAND: IVIG (Gamunex-C) Treatment Study for POTS Subjects (clinicaltrials.gov) - P1/2; N=20; Enrolling by invitation; Sponsor: University of Texas Southwestern Medical Center; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Jul 2020 ➔ Jul 2021

Clinical • Trial completion date • Trial primary completion date • Cardiovascular • Hematological Disorders • Immune Modulation • Immunology • Rheumatoid Arthritis

Subconjunctival IVIg (Gamunex-C) Injection for Corneal Neovascularization and Inflammatory Conditions (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: University of Utah; Initiation date: Jan 2014 ->May 2014

Trial initiation date • Biosimilar • Immunology