Siltuximab filed at FDA and EU for Castleman disease

Janssen Research & Development, LLC has announced the simultaneous submissions of a Biologic License Application (BLA) to the 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. 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. Currently, there are no approved treatments in the U.S. or European Union (EU) for this rare blood disorder,