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

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