EU/3/07/508: Orphan designation for the treatment of Castleman's disease

Chimeric anti-interleukin-6 monoclonal antibody (siltuximab)


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.

Key facts

Active substance
Chimeric anti-interleukin-6 monoclonal antibody (siltuximab)
Medicine name
Intended use
Treatment of Castleman's disease
Orphan designation status
EU designation number
Date of designation

Recordati Netherlands B.V.
Beechavenue 54
1119 PW


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.

Update history

August 2023The sponsor’s name was changed from EUSA Pharma (Netherlands) B.V. to Recordati Netherlands B.V. in August 2023.

Documents related to this orphan designation evaluation

  • List item

    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

  • Patients' organisations

    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:

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