Baxter files for European approval for 20 percent IGSC for primary immunodeficiencies.
Baxter International Inc. announced that its BioScience business has submitted a marketing authorization application (MAA) to 17 competent authorities in Europe following the decentralized procedure (DCP) for approval of its investigational 20 percent concentration subcutaneous immune globulin (IGSC) treatment for primary immunodeficiencies (PI, a group of disorders in which part of the body's immune system is missing or does not function properly).
The filing is based on the positive results of a Phase II/III study that evaluated the efficacy, safety, tolerability and pharmacokinetics (PK) of IGSC 20 percent in European patients at least two years old with PI. The study met its primary endpoint that measured the rate of validated acute serious bacterial infections (VASBIs); these results were initially presented during the 2014 biennial congress of the European Society for Immunodeficiencies (ESID).
Results from a separate study of IGSC 20 percent among PI patients in North America are expected to be available next year.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.