EU/3/08/548

About

On 3 June 2008, orphan designation (EU/3/08/548) was granted by the European Commission to Interface International Consultancy Ltd, United Kingdom, for carfilzomib for the treatment of multiple myeloma.

The sponsorship was transferred as follows:

  • to Nexus Oncology Ltd, United Kingdom, in October 2008;
  • to Onyx Pharmaceuticals (UK) Ltd, United Kingdom, in November 2012 and
  • to Amgen Europe BV, The Netherlands, in June 2014.

Update: Carfilzomib (Kyprolis) has been authorised in the EU since 19 November 2015. Kyprolis in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.

Key facts

Active substance
carfilzomib
Medicine name
Kyprolis
Disease / condition
Treatment of multiple myeloma
Date of first decision
03/06/2008
Outcome
Positive
EU designation number
EU/3/08/548

Review of designation

During its meeting of 6 to 8 October 2015, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/08/548 for Kyprolis (carfilzomib) as an orphan medicinal product for the treatment of multiple myeloma. 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 multiple meyloma. The COMP recommended that the orphan designation of the medicine be maintained*.


*The 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

Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands
Tel. +31 7657 32000
Fax +31 7657 32002
E-mail: medinfointernational@amgen.com

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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