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EC approves Janssen rare blood disorder drug

Sylvant available to treat multicentric Castleman's disease

Janssen logoJanssen's Sylvant this week became the first drug approved in Europe to treat the rare blood disorder multicentric Castleman's disease (MCD).

The condition causes white blood cells to over-produce leading to the enlargement of lymph nodes and damage to internal organs and has been described as being similar to the cancer lymphoma.

There is also a unicentric form of the condition, which affects only a single area or group of lymph node and can be treated with surgery.

However, the multicentric form of the condition affects lymphoid tissue around the body and is much harder to treat, with current therapies, such as corticosteroids, chemotherapy and immunotherapy, having limited success.

Sylvant (siltuximab) offers a more promising alternative, however, and has demonstrated in clinical trials it can reduce the size of tumours and stabilise disease symptoms, such as fever.

Not every MCD patient will be eligible for treatment with Sylvant (siltuximab), however, as the approval only covers patients who do not have either HIV or human herpes virus-8.

This reduces an already limited patient population for Sylvant as “MCD is so rare that it is difficult to track the number of cases across Europe”, according to Janssen, the pharma division of Johnson & Johnson.

Nevertheless, the drug is an important step in treatment in this area of unmet medical need, and is tipped to become a standard of care.

“As the first company with an approved medicine to treat MCD in Europe, we are very proud to be able to offer an effective treatment option for eligible patients with this rare and challenging disease and further demonstrate our commitment to patients,” said Jane Griffiths, company group chairman of Janssen EMEA.

The European Commission's decision to greenlight Sylvant comes shortly after its April approval by the US FDA.

Article by
Thomas Meek

5th June 2014

From: Sales



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