The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Sylvant (siltuximab) for adult patients with multicentric Castleman’s disease.
Castleman’s disease is a rare disorder characterized by non-cancerous growth of the lymph nodes and related tissues. There are currently no medicinal products authorized in the European Union for its treatment.
Janssen-Cilag’s Sylvant, shown in clinical trials to reduce tumor burden and improve disease symptoms, was developed using incentives put in place by Europe’s orphan legislation. It was designated as an orphan medicine in 2007; at that time it was estimated that Castleman’s disease affected less than 1 in 10,000 people in the EU.