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EMA backs Janssen rare disease drug for approval

Castleman's disease treatment Sylvant wins CHMP recommendation

European Medicines Agency (EMA)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.

Staying in the orphan disease area the CHMP also gave the nod to Endocyte's Vynfinit (vintafolide), a treatment for platinum-resistant ovarian cancer, along with two companion diagnostic drugs Folcepri (etarfolatide) and Neocepri (folic acid) used to identify patients who will benefit from treatment with the drug.

Vynfinit will be commercialised by Merck & Co and last year the drug's prospects were boosted by trial results showing it was an improvement on standard treatment for women with ovarian cancer.

All three agents are classed as orphan drugs as they are targeted for use only in a sub-population of patients whose tumours express high levels of folate receptors, a form of ovarian cancer associated with very poor prognosis.

At the moment the only treatment option for these patients is Johnson & Johnson's Doxil (pegylated doxorubicin), although this is subject to shortages in a number of markets because of manufacturing problems.

Article by
Phil Taylor

24th March 2014

From: Sales, Regulatory



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