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: 16 Nov 2016
At a glance
- Drugs Immune globulin (Primary)
- Indications Immunodeficiency disorders
- Focus Adverse reactions; Pharmacokinetics
- Sponsors Baxalta; Baxter Healthcare Corporation
- 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.
- 10 Jun 2016 According to a Shire media release, the company expects a regulatory decision for Cuvitru in the US later in 2016.
- 15 Sep 2015 According to Baxalta media release, company has submitted to the US FDA for approval of IGSC 20%.