EU/3/11/879

About

On 21 June 2011, orphan designation (EU/3/11/879) was granted by the European Commission to United Therapeutics Europe Ltd, United Kingdom, for chimeric monoclonal antibody against GD2 for the treatment of neuroblastoma.

Chimeric monoclonal antibody against GD2 was authorised in the EU as Unituxin on 14 August 2015.

This medicine is now known as dinutuximab.

The marketing authorisation was withdrawn on 20 March 2017.

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products by the European Commission in March 2017 at the time of withdrawal of the marketing authorisation.

Key facts

Active substance
Chimeric monoclonal antibody against GD2 (dinutuximab)
Medicine name
Unituxin
Disease / condition
Treatment of neuroblastoma
Date of decision
21/06/2011
Outcome
Withdrawn
Orphan decision number
EU/3/11/879

Review of designation

The marketing authorisation was withdrawn on 20 March 2017.

During its meeting of 16 to 18 June 2015, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/11/879 for Unituxin (dinutuximab) for the treatment of neuroblastoma. 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 methods of treatment. As other methods of treatment are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with neuroblastoma. 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.

Sponsor's contact details

United Therapeutics Europe Ltd
Unither House
Curfew Bell Road
Chertsey
Surrey KT16 9FG
United Kingdom
Tel. +44 (0)1932 573800
Fax +44 (0)1932 571110
E-mail: zinfo1@unither.com

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;

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