Janssen Biotech Gains FDA Approval for its mAb Sylvant

FDA has approved Sylvant (siltuximab) to treat patients with multicentric Castleman's disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes). Sylvant is marketed by Janssen Biotech Inc., based in Horsham, Pennsylvania. Sylvant is an anti-interleukin-6 (IL-6) chimeric monoclonal antibody that binds to human IL-6, a multifunctional cytokine produced by various cells such as T cells, B cells, monocytes, fibroblastsm and endothelial cells.

MCD causes an abnormal overgrowth of immune cells in lymph nodes and related tissues in the body. The disease usually affects adults who often suffer from fever, night sweats, weight loss, and weakness or fatigue because their body's immune system is weakened and cannot fight infections.Sylvant is an injection that works by blocking a protein that stimulates abnormal growth of immune cells. It is intended for patients with MCD who do not have HIV or human herpes virus 8 (HHV-8).

On September 3, 2013, Janssen announced simultaneous submissions of a biologic license application (BLA) to FDA and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for siltuximab for the treatment of patients with MCD who are HIV negative and HHV-8 negative. FDA granted the siltuximab BLA priority review in the US, and the EMA  granted accelerated assessment of the MAA. Siltuximab was granted orphan drug status in MCD in the US and European Union.

Source: FDA and Janssen Biotech

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