Panzyga (immune globulin intravenous, human-ifas) / Octapharma, Pfizer - LARVOL DELTA

Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: Octapharma | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Infectious Disease

NGAM-11: Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients (clinicaltrials.gov) - P3 | N=30 | Recruiting | Sponsor: Octapharma | Trial completion date: Jun 2026 ➔ Dec 2028 | Trial primary completion date: Jun 2026 ➔ Dec 2028

Trial completion date • Trial primary completion date • Pediatrics

Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections (clinicaltrials.gov) - P3 | N=360 | Not yet recruiting | Sponsor: Octapharma | Initiation date: Dec 2025 ➔ Jun 2026

Trial initiation date • Immunology • Infectious Disease

NGAM-16: Supporting weak immune system during autoimmune therapy: testing Panzyga to prevent infections (clinicaltrialsregister.eu) - P2/3 | N=215 | Not yet recruiting | Sponsor: Octapharma Pharmazeutika Produktionsgesellschaft mbH

New P2/3 trial • Immunology • Infectious Disease

NGAM-16: Supporting weak immune system during autoimmune therapy: testing Panzyga to prevent infections (clinicaltrialsregister.eu) - P2/3 | N=178 | Not yet recruiting | Sponsor: Octapharma Pharmazeutika Produktionsgesellschaft mbH

New P2/3 trial • Immunology • Infectious Disease

EMPIRICAL TIME-SERIES ANALYSES IN THE PAST THREE DECADES 1991-2023 FOR IMMUNE THROMBOCYTOPENIA MEDICATIONS IN THE US MEDICAID PROGRAMS (ISPOR 2026) - "Study medications target platelet count restoration and immune system modulation, including thrombopoietin receptor agonists (TPO-RA), such as Nplate (Romiplostim) and Promacta (Eltrombopag), and IV immunoglobulin (e.g., Gammagard) or anti-D immunoglobulin, Rituximab (an anti-CD20 monoclonal antibody), and newer Tyrosine kinase inhibitors...Comparative market-share analyses were also conducted within and across therapeutic classes Utilization trends revealed Rituxan dominated until 2020, after which biosimilars (Ruxience, Truxima) gained traction, with Ruxience leading. In the IVIG category, Gammagard consistently held the highest utilization, peaking in 2022, followed by Rhophylac and Privigen...Pricing data highlighted Promacta as the most expensive TPO-RA, while Panzyga led IVIG pricing by 2019... Analysis highlights evolving patterns in the utilization, reimbursement, and pricing of ITP therapies within Medicaid programs, shaped by factors such as the introduction of..."

Medicaid • Reimbursement • US reimbursement • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Evaluating the Safety and Efficacy of Different Intravenous Immunoglobulin 10 Percent Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients (AAN 2026) - "Design/Methods This is a multicenter, prospective, double-blinded, parallel-group, randomized phase III study to evaluate safety and efficacy of different IVIg 10% (PANZYGA®) dose regimens in pediatric CIDP patients...Secondary outcomes include the percentage of patients with CIDP relapse (increase in mRS score by ≥1 point from the baseline score related to CIDP), time to CIDP relapse, and the percentage of patients with good or excellent response (mRS score of 0 or 1 in each arm at Week 24). Conclusions Finding safe and effective doses of intravenous immunoglobulin 10% for CIDP in the pediatric population can improve their quality of life."

Clinical • Pain • Pediatrics

Supporting Weak Immune System During Autoimmune Therapy: Testing Panzyga to Prevent Infections (clinicaltrials.gov) - P3 | N=360 | Not yet recruiting | Sponsor: Octapharma

New P3 trial • Immunology • Infectious Disease

PROSID: Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia ("PRO-SID" Study) (clinicaltrials.gov) - P3 | N=247 | Completed | Sponsor: Octapharma | Active, not recruiting ➔ Completed

Trial completion • Chronic Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Oncology

IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Endeavor Health | Active, not recruiting ➔ Recruiting | Trial completion date: Apr 2027 ➔ Feb 2028 | Trial primary completion date: Dec 2026 ➔ Aug 2027

Enrollment open • Trial completion date • Trial primary completion date • Immunology • Pain

Empirical Time-Series Analysis (1991–2023) of Immune Thrombocytopenia Medications in U.S. Medicaid Programs (ISPOR 2025) - "Comparative market-share analyses were conducted across therapeutic classes to identify key drivers of market changes, including policy shifts, competition, and new drug entries The utilization trends revealed Rituxan dominated until 2020, after biosimilars (Ruxience, Truxima) gained traction, with Ruxience leading. In the IVIG category, Gammagard consistently held the highest utilization, peaking in 2022, followed by Rhophylac and Privigen. Among TPO-RAs, Promacta surpassed Nplate in 2018, reflecting a shift in prescribing patterns. Pricing data highlighted Promacta as the most expensive TPO-RA, Panzyga led IVIG pricing by 2019... This analysis highlights evolving patterns in the utilization, reimbursement, and pricing of ITP therapies within Medicaid programs, shaped by factors like the introduction of biosimilars, competitive market dynamics, and clinical advancements. These findings provide valuable insights for healthcare policymakers, payers, and clinicians to..."

Medicaid • Reimbursement • US reimbursement • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

IVIG in the Treatment of Autoimmune Small Fiber Neuropathy with TS-HDS, FGFR-3, or Plexin D1 Antibodies (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: Henry Ford Health System | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Pain

NGAM-13: Phase III Study To Compare The Effect of Panzyga Versus Placebo in Patients With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS/PANDAS) (clinicaltrials.gov) - P3 | N=71 | Completed | Sponsor: Octapharma | Active, not recruiting ➔ Completed

Head-to-Head • Trial completion • Pediatrics • Psychiatry

PROSID: Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia ("PRO-SID" Study) (clinicaltrials.gov) - P3 | N=240 | Active, not recruiting | Sponsor: Octapharma | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Oncology

Study to Evaluate the Efficacy and Safety of PANZYGA in Pediatric Patients With Chronic Immune Thrombocytopenia (ITP) (clinicaltrials.gov) - P4 | N=6 | Terminated | Sponsor: Octapharma | N=20 ➔ 6 | Active, not recruiting ➔ Terminated | Trial primary completion date: Apr 2024 ➔ Sep 2023; FDA released Octapharma from the pediatric post marketing requirement.

Enrollment change • Trial primary completion date • Trial termination • Hematological Disorders • Pediatrics • Thrombocytopenia • Thrombocytopenic Purpura

NGAM-13: Phase III Study To Compare The Effect of Panzyga Versus Placebo in Patients With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS/PANDAS) (clinicaltrials.gov) - P3 | N=71 | Active, not recruiting | Sponsor: Octapharma | Trial completion date: Jun 2024 ➔ Oct 2024 | Trial primary completion date: Jun 2024 ➔ Oct 2024

Head-to-Head • Trial completion date • Trial primary completion date • Pediatrics • Psychiatry

NGAM-13: Phase III Study To Compare The Effect of Panzyga Versus Placebo in Patients With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS/PANDAS) (clinicaltrials.gov) - P3 | N=70 | Active, not recruiting | Sponsor: Octapharma | Terminated ➔ Active, not recruiting

Enrollment closed • Head-to-Head • Pediatrics • Psychiatry

NGAM-13: Phase III Study To Compare The Effect of Panzyga Versus Placebo in Patients With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS/PANDAS) (clinicaltrials.gov) - P3 | N=70 | Terminated | Sponsor: Octapharma | Trial completion date: Oct 2024 ➔ May 2024 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2024 ➔ May 2024; Medical Director decision; statistical considerations unrelated to safety

Head-to-Head • Trial completion date • Trial primary completion date • Trial termination • Pediatrics • Psychiatry

PROSID: Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia ("PRO-SID" Study) (clinicaltrials.gov) - P3 | N=240 | Recruiting | Sponsor: Octapharma | Trial completion date: Oct 2024 ➔ Aug 2025 | Trial primary completion date: Oct 2024 ➔ Aug 2025

Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Oncology

Study to Evaluate the Efficacy and Safety of PANZYGA in Pediatric Patients With Chronic Immune Thrombocytopenia (ITP) (clinicaltrials.gov) - P4 | N=20 | Active, not recruiting | Sponsor: Octapharma | Recruiting ➔ Active, not recruiting

Enrollment closed • Hematological Disorders • Pediatrics • Thrombocytopenia • Thrombocytopenic Purpura

IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Henry Ford Health System | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Pain

PROSID: Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia ("PRO-SID" Study) (clinicaltrials.gov) - P3 | N=240 | Recruiting | Sponsor: Octapharma

Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Oncology

IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Henry Ford Health System

Trial completion date • Trial primary completion date • Immunology • Pain

NGAM-11: Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients (clinicaltrials.gov) - P3 | N=30 | Recruiting | Sponsor: Octapharma | Not yet recruiting ➔ Recruiting

Enrollment open • Pain • Pediatrics

An early onset of acute Inflammatory Demyelinating Polyneuropathy (AIDP) or Guillain-Barre Syndrome along with Covid-19. (EUSEM 2023) - "Treatment was substituted with intravenous immunoglobulin therapy (Panzyga 100 mg/ml, 150g in total)...It is important to mention that the patient had a Sars-cov-19 infection and this specific finding illustrates how there is a variety of infectious diseases that can lead to GBS. Plasmapheresis can cause an allergic reaction, but it is vital to attempt second line treatment, such as intravenous immunoglobulin therapy."

Allergy • Cardiovascular • Complement-mediated Rare Disorders • Gastrointestinal Disorder • Hematological Disorders • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases