Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human) 10% (IGIV, 10%) Administered Intravenously or Subcutaneously in Subjects With Primary Immunodeficiency Diseases
Phase of Trial: Phase II/III
Latest Information Update: 26 Feb 2018
At a glance
- Drugs Immune globulin (Primary)
- Indications Immunodeficiency disorders
- Focus Adverse reactions; Pharmacokinetics
- Sponsors Baxter Healthcare Corporation
- 11 Jan 2018 Baxalta merged with Shire in Jun 3, 2016.
- 11 Jan 2018 Baxalta is the former Baxter BioScience global biopharmaceutical business spun off in July of 2015 by Baxter International with a focus on developing new treatments for people with orphan diseases and underserved conditions in three areas of therapeutic focus .
- 16 Nov 2016 According to a Shire media release, based on the data from this and another phase III study (profile 278874), the U.S. Food and Drug Administration (FDA) has approved CUVITRU in September 2016 as a subcutaneous immune globulin (IG) replacement therapy for primary immunodeficiency.