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Siltuximab: First Global Approval

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Abstract

The anti-interleukin-6 (IL-6) chimeric monoclonal antibody siltuximab is the first drug to be approved for the treatment of multicentric Castleman’s disease (MCD) in the US and European union (EU), having gained approval under the FDA priority review program in the US and from an accelerated assessment and recommendation by the Committee for Medicinal Products for Human Use (CHMP) in the EU. Development of the drug is continuing in smoldering multiple myeloma. This article summarizes the milestones in the development of siltuximab leading to this first approval for MCD.

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Disclosure

The preparation of this report was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. A. Markham is a contracted employee of Adis, Springer SBM. T. Patel is a salaried employee of Adis, Springer SBM.

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Authors and Affiliations

  1. Adis, Auckland, New Zealand

    Anthony Markham

  2. Adis, Level 1, 5 The Warehouse Way, Northcote 0627; Private Bag 65901, Mairangi Bay 0754, Auckland, New Zealand

    Trina Patel

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  1. Anthony Markham
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  2. Trina Patel
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Correspondence to Trina Patel.

Additional information

This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

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Markham, A., Patel, T. Siltuximab: First Global Approval. Drugs 74, 1147–1152 (2014). https://doi.org/10.1007/s40265-014-0249-x

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