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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

RARITAN, N.J., Sept. 3, 2013 /PRNewswire/ -- Janssen Research & Development, LLC ("Janssen") announced the simultaneous submissions of a Biologic License Application (BLA) to the United States Food and Drug Administration (U.S. FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for siltuximab for the treatment of patients with multicentric Castleman disease (MCD) who are HIV-negative and human herpes virus-8 (HHV-8)-negative.

MCD is a rare disorder in which lymphocytes, a certain type of white blood cells, are over-produced and lead to enlargement of lymph nodes.1, 2 This can cause a variety of symptoms and weaken the immune system, making it hard to fight infection. Infections in people with MCD can be very serious and may even be fatal.3 Currently, there are no approved treatments in the U.S. or European Union (EU) for this rare blood disorder.

"We're proud of our work on siltuximab. As a rare disease with a small patient population, MCD is an area of significant unmet need," said Peter F. Lebowitz, M.D., Ph.D., global oncology therapeutic area head, Janssen. "Siltuximab works by targeting interleukin-6 which appears to be the critical driver of this disease. By focusing on core biologic mechanisms, we now have the potential of helping patients with a condition that is challenging to treat."  

Siltuximab has been granted orphan drug status in MCD in the U.S. and EU. The siltuximab regulatory submissions include data from a randomized, multi-national, double-blind, placebo-controlled study (MCD2001) and data from two non-randomized supportive studies. The MCD2001 study assessed the efficacy and safety of siltuximab plus best supportive care (BSC) compared with placebo plus BSC in patients with MCD.4 In the study, 79 patients were randomly assigned in a 2:1 ratio to one of the two treatment
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SOURCE Janssen Research & Development, LLC
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