DEERFIELD (dpa-AFX) - Baxter International Inc. (BAX) announced that its BioScience business has submitted a marketing authorization application or MAA to 17 competent authorities in Europe following the decentralized procedure or 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 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.
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