Sunday, March 23, 2014

First medicine on Castleman disease a rare disorder gets EMA approval


Castleman’s disease is an uncommon lymphoproliferative disorder that may be localized to a single lymph node (unicentric) or occur systemically (multicentric). It is a non-cancerous growth of the lymph nodes and related tissues, but it is associated with a higher risk of a type of cancer called lymphoma.

Affected patients have an increased risk of infection, kidney failure and certain cancers. Castleman’s disease is life threatening, especially for patients with more than one affected lymph node. The most common Symptoms are high fevers, anemia, weight loss, loss of appetite, and low white blood cell counts, which may to be due to the overproduction of interleukin 6.

Sylvant (siltuximab), a medicine for the treatment of adult patients with multicentric Castleman’s disease who are HIV negative and human herpesvirus‑8 (HHV‑8) negative have received European Medicines Agency (EMA) recommendation for MAA under orphan legislation. The active substance of Sylvant is siltuximab, a human‑mouse chimeric monoclonal antibody that specifically binds to and neutralizes human IL-6 with high affinity.

There are currently no medicinal products authorized in the European Union (EU) for the treatment of Castleman’s disease. In clinical trials, Sylvant has shown its ability to reduce tumour burden and improve the symptoms of the disease with a safety profile.

The CHMP opinion on Sylvant will now be sent to the European Commission for adoption of a decision on an EU-wide marketing-authorization.


 

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