Drugs / Ig20Gly
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/3 | NCT01412385 | Jun 2011 → May 2014 | immunodeficiency disease | Baxalta now part of Shire | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 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. |
All press releases naming this drug 6 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ig20Gly | “This pooled analysis evaluated the safety and tolerability of the subcutaneous immunoglobulin 20% product, Ig20Gly, in primary immunodeficiency diseases using data from two...” PMID 31268374 ↗ Jul 2019 |
| Known as | Cuvitru | “weekly 20% subcutaneous IG (SCIG; Cuvitru, Ig20Gly)” PMID 34036490 ↗ May 2021 |
| Action | Restore | “antibody replacement therapy” PMID 27613250 ↗ Oct 2016 |
| Modality | Protein / enzyme biologic | “A highly concentrated (20%) immunoglobulin (Ig)G preparation for subcutaneous administration” PMID 27613250 ↗ Oct 2016 |
| Route | Subcutaneous | “Subcutaneous infusion (regulated via a pump), Epoch 2 only (all subjects)” NCT01412385 ↗ |