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Simultaneous Applications Submitted to FDA and EMA for Siltuximab for the Treatment of Multicentric Castleman Disease, a Rare Blood Disorder
Date:9/3/2013

groups, with 53 receiving siltuximab and BSC, and 26 receiving placebo and BSC.5 Results of the primary study analysis have been submitted for presentation at a medical meeting later this year.

About Multicentric Castleman Disease
Unlike "unicentric" Castleman disease, which is localized and affects only a single area or group of lymph nodes,6 patients with MCD have more than one group of lymph nodes in different anatomical areas that are affected.3 Unicentric disease can be treated by surgically removing the diseased lymph node,7 while multicentric disease is usually much more difficult to treat.8 Currently, the focus of care is to reduce lymph node masses9, 10 and to attempt to put the disease in remission through a combination of treatments, including corticosteroids, chemotherapy and immunotherapy. While such treatments may initially help, the disease often returns.8

MCD can also affect lymphoid tissue of internal organs, causing the liver, spleen, or other organs to enlarge.11 Some symptoms can be life threatening.9,10 The most common symptoms include fever, weakness, fatigue, night sweats, weight loss, loss of appetite, nausea, vomiting and nerve damage that leads to numbness and weakness.3 Infections, renal failure, and malignancies including malignant lymphoma and Kaposi's sarcoma are common causes of death in patients with MCD.9,10 Castleman disease is formally diagnosed through a biopsy.11 The number of people diagnosed with Castleman disease is unknown, but the disease is known to be rare.12

About Siltuximab
Siltuximab is an investigational, anti Interleukin-6 (IL-6) chimeric monoclonal antibody that targets and binds to human IL-6. IL-6 is a multifunctional cytokine produced by various cells such as T cells, B cells, monocytes, fibroblasts and endothelial cells.'/>"/>

SOURCE Janssen Research & Development, LLC
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