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.
The sponsor’s address was updated in August 2021.
Chimeric monoclonal antibody against GD2
Dinutuximab beta Apeiron
Treatment of neuroblastoma
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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.
Documents related to this orphan designation evaluation
Recommendation for maintenance of orphan designation at the time of marketing authorisation: Dinutuximab beta Apeiron (dinutuximab beta) for the treatment of neuroblastoma (PDF/80.44 KB)
First published: 24/05/2017
Last updated: 24/05/2017
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: