EU/3/12/1062

About

On 8 November 2012, orphan designation (EU/3/12/1062) was granted by the European Commission to Apeiron Biologics AG, Austria, for chimeric monoclonal antibody against GD2 for the treatment of neuroblastoma.

This medicine is now known as dinutuximab beta.

Chimeric monoclonal antibody against GD2 has been authorised in the EU as Dinutuximab beta EUSA since 8 May 2017.

The sponsorship was transferred to EUSA Pharma (UK) Limited, United Kingdom, in September 2017.

The sponsorship was transferred to EUSA Pharma (Netherlands) B.V, Netherlands, in January 2019.

Key facts

Active substance
Chimeric monoclonal antibody against GD2
Medicine name
Dinutuximab beta Apeiron
Disease / condition
Treatment of neuroblastoma
Date of first decision
08/11/2012
Outcome
Positive
EU designation number
EU/3/12/1062

Review of designation

On 18 April 2017, the Committee for Orphan Medicinal Products (COMP) completed its review of the designation EU/3/12/1062 for Dinutuximab beta Apeiron (dinutuximab beta, previously known as chimeric monoclonal antibody against GD2) as an orphan medicinal product 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 maintained.1


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 the same therapeutic indication cannot be placed on the market.

Sponsor's contact details

Johannes Vermeerplein 11
1071 DV Amsterdam
Netherlands
Tel: +31 858883207
E-mail: regulatory-eusa@eusapharma.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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