EU/3/09/672: Orphan designation for the treatment of multiple myeloma

Pomalidomide

Overview

Pomalidomide has been authorised in the EU as Imnovid since 5 August 2013.

On 8 October 2009, orphan designation (EU/3/09/672) was granted by the European Commission to Celgene Europe Limited, United Kingdom, for pomalidomide for the treatment of multiple myeloma.

The sponsorship was transferred to Celgene Europe B.V., The Netherlands, in July 2018.

The sponsorship was transferred to Bristol-Myers Squibb Pharma EEIG in June 2021.

Key facts

Active substance
Pomalidomide
Medicine name
Imnovid
Intented use
Treatment of multiple myeloma
Orphan designation status
Positive
EU designation number
EU/3/09/672
Date of designation
08/10/2009
Sponsor

Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland
Tel. +353 1 483 3857
E-mail: medical.information@bms.com

Review of designation

During its meeting of 11-13 June 2013, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/09/672 for Imnovid, previously Pomalidomide Celgene, (pomalidomide) 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 satisfactory methods of treatment. As other methods of treatment for patients with this condition are authorised in the European Union (EU), the COMP also looked at the significant benefit of the product over existing treatments. 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.

The Committee for Orphan Medicinal Products reviewed the orphan designation of Imnovid at the time of change to the terms of the marketing authorisation, and confirmed that the orphan designation should be maintained. 

More information is available in the PDF icon orphan medicine assessment report .

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Pomalidomide Celgene (pomalidomide) for the treatment of multiple myeloma (PDF/80.44 KB)

    Adopted

    First published: 20/08/2013
    Last updated: 16/10/2014
    EMA/351975/2013 Rev.1

  • 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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