J&J subsidiary Janssen-Cilag's Castleman's disease treatment Sylvant (situximab) has been recommended for approval in Europe.
Sylvant, which was filed for approval in Europe and the US in September, is a monoclonal antibody that works by targeting interleukin-6, which is a cytokine, or cell signalling molecule, that is thought to be the critical driver of multicentric Castleman disease.
The positive opinion by the EMA's scientific advisory committee puts the orphan drug on course for approval by the European Commission within the next two months.
Castleman's disease is a rare disorder characterised by non-cancerous growth of lymphatic tissue that puts patients at an increased risk of infection, kidney failure and certain cancers.
The chronically debilitating and life threatening disease is thought to affect less than 1 in 10,000 people in the EU where, to date, no therapies have been approved to treat it...