Drugs / Immune Globulin Infusion 10% (Human)
Immune Globulin Infusion 10% (Human)
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02549170 | Dec 2015 → Feb 2022 | chronic inflammatory demyelinating polyradiculoneuropathy | Baxalta now part of Shire | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 2024-01-16 | Takeda | Regulatory U.S. FDA Approves Takeda’s HYQVIA ® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) takeda.com ↗
Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved HYQVIA ® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults. |
All press releases naming this drug 2 releases
Evidence & citations 3 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 10% (Human) | “Participants will receive HYQVIA/HyQvia SC which contains both Immune Globulin Infusion 10% (Human) (IGI, 10%) and recombinant human hyaluronidase (rHuPH20).” NCT02549170 ↗ |
| Modality | Protein / enzyme biologic | “Immune Globulin Infusion 10% (Human) (IGI, 10%)” NCT02549170 ↗ |
| Route | Subcutaneous | “HYQVIA/HyQvia SC which contains both Immune Globulin Infusion 10% (Human)” NCT02549170 ↗ |