J&J files siltuximab in US and EU for rare blood disorder

In Clinical Development, Regulation & Government by Tim PeplowLeave a Comment

j&j siltuximab (Luis García)

Johnson & Johnson’s Janssen unit has filed siltuximab in the US and EU for the treatment of patients with the rare blood disorder, multicentric Castleman disease (MCD). The disorder leads to the over-production of lymphocytes and enlargement of lymph nodes. Siltuximab has orphan drug status in the US and Europe, and if approved would be the first drug specifically for the treatment of MCD.

The market application submitted by Janssen is for the use of siltuximab in patients with MCD who do not have HIV or human herpes virus-8. The monoclonal antibody targets and binds to human IL-6, which has been identified as a critical driver in the pathogenesis of MCD. The results of siltuximab’s MCD2001 study will be presented at a medical meeting later this year.

Read the press release >

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