drugset
Drugs / Immune Globulin Infusion 10% (Human)
last change Dec 2024 re-read 9 days ago

Immune Globulin Infusion 10% (Human)

Protein / enzyme biologic

Developed for
immunodeficiency disease
Investigated by
Baxalta Innovations GmbH, now part of Shire · Baxalta now part of Shire

Trials 1

today NCT03277313 · Ph 3
2018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT03277313 Sep 2017 → Jul 2022 immunodeficiency disease Baxalta now part of Shire Completed No outcome recorded

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2024-12-27 Takeda Regulatory Takeda Announces Approval of HYQVIA® 10% S.C. (Subcutaneous) Injection Set in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia takeda.com ↗
The approval marks availability of the first and only facilitated subcutaneous immunoglobulin (fSCIG) therapy as a treatment option for appropriate patients in Japan.
2024-06-18 Takeda Results Takeda Presents Long-Term Data from Phase 3 ADVANCE-CIDP 3 Clinical Trial of HYQVIA® in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) at PNS Annual Meeting takeda.com ↗
Results showed favorable long-term safety and tolerability of HYQVIA, and a low relapse rate, supporting its use as maintenance treatment for CIDP.
2024-01-16 Takeda Regulatory U.S. FDA Approves Takeda’s HYQVIA ® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) takeda.com ↗
2023-12-15 Takeda Regulatory Takeda Receives Positive CHMP Opinion for HYQVIA® as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) takeda.com ↗
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.

All press releases naming this drug 5 releases

DateIssuerRelease

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as Immune Globulin Infusion 10% (Human) “Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (IGI, 10% with rHuPH20)” NCT03277313 ↗
Modality Protein / enzyme biologic “Immune Globulin Infusion 10% (Human)” NCT03277313 ↗