Baxter BioScience files for primary immunodeficiency product approval in Europe

US health care product company Baxter International (NYSE: BAX) has submitted a marketing authorization application (MAA) to 17 competent authorities in Europe following the decentralized procedure (DCP) for approval of its investigational 20% 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 firm’s Baxter BioScience unit is advancing the 20% treatment as part of its efforts to expand the primary immunodeficiency treatment portfolio to address patient needs.

''The data we’ve collected on our investigational 20 percent treatment support its potential role as a valuable alternative to other conventional IGSC products for patients with immunodeficiency disorders and have formed the basis of our regulatory submission in Europe,'' said John Orloff, vice president and global head of R&D for Baxter BioScience, adding: ''As we build on our legacy of innovation in the interest of patients worldwide, we aim to identify and address priorities for our patient communities around the world. We are confident that this product will support these efforts and enhance the value of our immunology portfolio to the PI community.''