I don’t know; was mainly jerking mcbio’s chain, although I do think the rejected application might be Simeprevir. The FDA has granted so many BT designations for HCV, JNJ may have figured there was nothing to lose by trying.
Siltuximab - Simultaneous Applications Submitted to FDA and EMA for Siltuximab for the Treatment of Multicentric Castleman Disease, a Rare Blood Disorder
RARITAN, NJ, September 3, 2013 – 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 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.
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