Drugs / Subcutaneous immunoglobulin
Trials 0
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT04728425 Comparator | Aug 2020 → Jun 2023 | myasthenia gravis | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 2 | NCT01017159 Comparator | Apr 2010 → Nov 2011 | chronic inflammatory demyelinating polyradiculoneuropathy | University of Aarhus | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| 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. |
| 2024-06-18 | 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. |
| 2024-01-29 | Takeda | Regulatory Takeda’s HYQVIA® Approved by European Commission as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) takeda.com ↗ |
| 2023-09-25 | Takeda | Regulatory Takeda Announces Approval of CUVITRU Subcutaneous Immunoglobulin in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia takeda.com ↗
Takeda ( TSE:4502/NYSE:TAK ) today announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of CUVITRU™ [Immune Globulin Subcutaneous (Human), 20% Solution] in patients with agammaglobulinemia or hypogammaglobulinemia 1 , disorders characterized by very low or absent levels of antibodies and an increased risk of serious recurring infection caused by primary immunodeficiency (PID) or secondary immunodeficiency (SID) 2 . |
| 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. |
| 2017-03-06 | Takeda | Results CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] Data Demonstrate Improved Treatment Satisfaction Relative to Patients’ Previous Immunoglobulin Therapy takeda.com ↗
This analysis compares the treatment satisfaction of patients with PI during the two CUVITRU pivotal studies (North American and European) after the IVIG and CUVITRU treatment period. |
| 2016-09-14 | Takeda | Regulatory Shire announces U.S. FDA approval of CUVITRU™ [immune globulin subcutaneous (human), 20% solution] treatment for Primary Immunodeficiency takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the United States Food and Drug Administration (FDA) has granted approval for CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] in adult and pediatric patients two years of age and older. |
| 2010-02-26 | CSL Behring | Results European Data Suggest Switching Patients to IgPro20 May Significantly Reduce Drug Administration Volume csl.com ↗
No apparent difference in trough levels between IgPro20 and previous 16 percent SCIg were found. |
All press releases naming this drug 8 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Subcutaneous immunoglobulin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01017159 ↗ |
| Known as | SCIG | “subcutaneous immunoglobulin (SCIG)” NCT04728425 ↗ |
| Modality | Protein / enzyme biologic | “subcutaneous immunoglobulin” NCT01017159 ↗ |
| Route | Subcutaneous | “administered subcutaneously (SCIg)” NCT01017159 ↗ |