Gammagard S/D (human immune globulin intravenous 5%) / Takeda - LARVOL DELTA

Ivig: An unlikely culprit of fixed drug eruption (SID 2026) - "The patient had previously been misdiagnosed with HSV-1 and treated with daily valacyclovir without improvement. In addition to IVIG, the patient was taking cetirizine and acetaminophen...The preparation used, Gammagard SD, contains IgG with trace IgA and IgM, as well as stabilizers such as human albumin, glycine, glucose, polyethylene glycol, tri-n-butyl phosphate, octoxynol, and polysorbate 80...This case represents a rare instance of FDE induced by IVIG. Clinicians should consider IVIG among potential etiologies in patients developing fixed drug eruptions during immunoglobulin therapy."

Dermatitis • Dermatopathology • Immunology • Lichen Planus • Primary Immunodeficiency

Takeda Announces U.S. FDA Approval of GAMMAGARD LIQUID ERC, the Only Ready-to-Use Liquid Immunoglobulin Therapy with Low Immunoglobulin A (IgA) Content (Businesswire) - "In parallel to this approval, and after thorough analysis, Takeda has decided to discontinue GAMMAGARD S/D [Immune Globulin Intravenous (Human)] IgA less than 1 µg/mL in a 5% solution, the company’s first-generation low IgA product. As the only lyophilized (freeze-dried) preparation in Takeda’s IG portfolio, GAMMAGARD S/D uses a different, older manufacturing process. For GAMMAGARD S/D, this process is no longer able to reliably meet the future needs of the patient community. Therefore, Takeda has informed the FDA and other health authorities that manufacturing of GAMMAGARD S/D will be discontinued at the end of December 2027. Beyond that date, Takeda intends to maintain GAMMAGARD S/D inventory until it is depleted or expired."

Discontinued • Primary Immunodeficiency

TREATMENT PATTERNS OF IMMUNOGLOBULIN REPLACEMENT THERAPY AMONG PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND SECONDARY IMMUNODEFICIENCY IN THE UNITED STATES: A REAL-WORLD ANALYSIS (EHA 2024) - "9% (n=408) received IVIG (n=6 used approved IVIG Gammagard S/D [1... These real-world data reveal that patient use of IgRT within 1 year after their index SID diagnosis is lower thanwhat would be expected, based on guidelines, at just 20. 2% despite the potential benefit of IgRT. Furthermore,low IgRT use, even in the highest risk subgroup, indicates a high unmet medical need for approved IgRT."

Clinical • Real-world • Real-world evidence • Chronic Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Oncology

Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma (clinicaltrials.gov) - P3 | N=53 | Completed | Sponsor: Children's Oncology Group | Active, not recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Dec 2022

Trial completion • Trial completion date • Ataxia • CNS Tumor • Movement Disorders • Neuroblastoma • Neuroendocrine Tumor • Oncology • Solid Tumor

A Study to Assess the Hypersensitivity to TAK-880 Compared to Gammagard S/D in Blood of Children, Teenagers and Adults (clinicaltrials.gov) - P=N/A | N=72 | Completed | Sponsor: Takeda | Recruiting ➔ Completed

Preclinical • Trial completion • Immunology

A Study to Assess the Hypersensitivity to TAK-880 Compared to Gammagard S/D in Blood of Children, Teenagers and Adults (clinicaltrials.gov) - P=N/A | N=60 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Preclinical • Immunology

A Study to Assess the Hypersensitivity to TAK-880 Compared to Gammagard S/D in Blood of Children, Teenagers and Adults (clinicaltrials.gov) - P=N/A | N=60 | Not yet recruiting | Sponsor: Takeda

New trial • Preclinical • Immunology

Shire opens $1B plant to make rare disease drugs (Fierce Pharma) - "Shire’s $1 billion plasma fractionation plant in Georgia has gone through three owners already since it was envisioned and will soon have a fourth. But after six years, it is now officially open...The company will make immunoglobulin products there to help patients with primary immune deficiency disorders."

Commercial • Immunology • Primary Immunodeficiency