On 30 November 2007, orphan designation (EU/3/07/508) was granted by the European Commission to Centocor, B.V., The Netherlands, for chimeric-anti-interleukin 6 monoclonal antibody for the treatment of Castleman's disease.
Centocor B.V. changed its name to Janssen Biologisc B.V. in July 2011.
The sponsorship was transferred to Janssen-Cilag International N.V., Belgium, in June 2013.
Chimeric-anti-interleukin 6 monoclonal antibody has been authorised in the EU as Sylvant since 22 May 2014.
This medicine is now known as siltuximab.
The sponsorship was transferred to EUSA Pharma (Netherlands) B.V, in July 2019.
The sponsor’s address was updated in August 2021.
Chimeric anti-interleukin-6 monoclonal antibody (siltuximab)
Treatment of Castleman's disease
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Review of designation
During its meeting of 8 to 9 April 2014, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/07/508 for Sylvant (siltuximab, previously known as chimeric-anti-interleukin 6 monoclonal antibody) as an orphan medicinal product for the treatment of Castleman's disease. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other satisfactory methods of treatment. The COMP recommended that the orphan designation of the medicine be maintained1.
1The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with a comparable therapeutic indication cannot be placed on the market.
Documents related to this orphan designation evaluation
Recommendation for maintenance of orphan designation at the time of marketing authorisation: Sylvant (siltuximab) for the treatment of Castleman’s disease (PDF/99.89 KB)
First published: 19/06/2014
Last updated: 19/06/2014
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: