Drugs / Cuvitru
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT05764993 | Jun 2023 → Feb 2025 | chronic obstructive pulmonary disease | Rochester General Hospital | Unknown | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT03737617 | Aug 2022 → Aug 2024 | bronchiectasis, selective IgG subclass deficiency | University of Edinburgh | Withdrawn | No outcome recorded |
| Phase 4 | NCT03116347 | May 2017 → Jan 2021 | immunodeficiency disease | Baxalta now part of Shire | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 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 . |
| 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. |
| 2016-11-12 | Takeda | Results Tolerability Data for Shire’s Cuvitru Accepted for Oral Presentation at the American College Of Allergy, Asthma & Immunology Annual Meeting takeda.com ↗
Of note, increased infusion volumes and rates were not associated with an increase in causally-related local adverse reactions, and infusions were well-tolerated during onboarding and throughout the study. |
| 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. |
| 2016-06-10 | Takeda | Regulatory Shire announces completion of decentralized procedure in Europe for Immunoglobulin Treatment Cuvitru takeda.com ↗
With the completion of the DCP, the 17 authorities mutually recognize approvability based on a scientific assessment of the product, and local marketing authorizations in Europe are expected to begin later in 2016. |
All press releases naming this drug 6 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cuvitru | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03737617 ↗ |
| Modality | Protein / enzyme biologic | “200 mg/ml solution for Immune Globulin Subcutaneous Injection” NCT03116347 ↗ |
| Route | Subcutaneous | “200 mg/ml solution for Immune Globulin Subcutaneous Injection” NCT03116347 ↗ |