Drugs / Immune Globulin Infusion
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT05084053 | Jan 2022 → Oct 2025 | chronic inflammatory demyelinating polyradiculoneuropathy, multifocal motor neuropathy | Takeda | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-06-30 | Takeda | Regulatory Takeda Announces U.S. FDA Approval of GAMMAGARD LIQUID ERC, the Only Ready-to-Use Liquid Immunoglobulin Therapy with Low Immunoglobulin A (IgA) Content 1 takeda.com ↗
Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID ERC [immune globulin infusion (human)] with less than or equal to 2 µg/mL IgA in a 10% solution, the only ready-to-use liquid immunoglobulin (IG) therapy with low immunoglobulin A (IgA) content, as replacement therapy for people two years of age and older with primary immunodeficiency (PI). |
| 2022-07-21 | Takeda | Results Takeda Announces Positive Topline Results from Pivotal Phase 3 Clinical Trial Evaluating HYQVIA ® for Maintenance Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) takeda.com ↗
Topline data show that HYQVIA reduced relapse of neuromuscular disability and impairment when used as a maintenance therapy for CIDP, supporting its potential as a facilitated subcutaneous immunoglobulin (fSCIG) solution that could allow for monthly infusion for many CIDP patients. |
| 2017-12-27 | Takeda | Regulatory Shire files for FDA approval of a new plasma manufacturing facility in Covington, Georgia to support growing Immunology franchise takeda.com ↗
The first submission is for the transfer of GAMMAGARD LIQUID® [Immune Globulin Infusion (Human)] 10% Solution, a replacement therapy for primary humoral immunodeficiency (PI). |
All press releases naming this drug 3 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Immune Globulin Infusion | “TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20).” NCT05084053 ↗ |
| Known as | IGI | “TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20).” NCT05084053 ↗ |
| Modality | Protein / enzyme biologic | “TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20).” NCT05084053 ↗ |
| Route | Subcutaneous | “Participants will receive subcutaneous infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the...” NCT05084053 ↗ |