Baxter BioScience Files for European Approval of Investigational 20% Subcutaneous Immune Globulin Treatment for Primary Immunodeficiency
Baxter International Inc. (NYSE:BAX) 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). Baxter is advancing the 20 percent 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, MD, vice president and global head of research and development for Baxter BioScience. ”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.”
The filing is based on the positive results of a Phase 2/3 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).
In the study, only one event of VASBI was reported during treatment with IGSC 20 percent, which equated to a low rate of 0.022/patient-year compared with the specified threshold of one VASBI/patient-year (P<0.0001). Importantly, nearly all infusions (99.8%) were completed without any interruption, slowing, or stopping the infusion. The rate of local adverse events (AEs) considered related to IGSC 20 percent treatment was 0.052/affected infusion (in 17 of 48 patients). The majority (99.8%) of local AEs were mild in severity and the most common events were erythema, swelling, pruritus, and pain/discomfort.
Results from a separate study of IGSC 20 percent among patients with PI in North America are expected to be available in the coming months; based on the outcome of this study, Baxter intends to file for U.S. approval of the treatment before the end of 2015.
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
This release includes forward-looking statements concerning Baxter’s IGSC 20 percent treatment and related clinical studies, including expectations with regard to regulatory filings and the potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply issues; patient safety issues; changes in law and regulations; and other risks identified in Baxalta Incorporated’s Form 10 and Baxter’s most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter’s website. Baxter does not undertake to update its forward-looking statements.
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