Janssen files for simultaneous US and EU approval for Castleman disease drug

Janssen Research & Development, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), yesterday (September 3) made simultaneous submissions of a Biologic License Application to the US Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency for siltuximab for the treatment of patients with multicentric Castleman disease (MCD) who are HIV-negative and human herpes virus-8 (HHV-8)-negative.

According to the company, siltuximab (CNTO 328), which is in late stage development for Castleman disease and multiple myeloma, is also being studied for smoldering myeloma, prostate cancer, muscular dystrophy syndrome and anemia.

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 USA or European Union for this rare blood disorder, the company noted.