EU/3/08/581: Orphan designation for the treatment of chronic lymphocytic leukaemia



On 7 November 2008, orphan designation (EU/3/08/581) was granted by the European Commission to Glaxo Group Limited, United Kingdom, for ofatumumab for the treatment of chronic lymphocytic leukaemia.

Ofatumumab was authorised in the EU as Arzerra on 19 April 2010.

The sponsorship was transferred to Novartis Europharm Limited, United Kingdom, in May 2015.

The sponsorship was transferred to Novartis Europharm Limited, Ireland, in September 2018.

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in December 2018 upon request of the marketing authorisation holder.

The marketing authorisation was withdrawn on 27 February 2019.

Key facts

Active substance
Medicine name
Intended use
Treatment of chronic lymphocytic leukaemia
Orphan designation status
EU designation number
Date of designation

Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Tel.: +41 (0)61 324 11 11

Review of designation

During its meeting of 2-3 February 2010, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/08/581 for Arzerra (ofatumumab) as an orphan medicinal product for the treatment of chronic lymphocytic leukaemia (CLL). The COMP reviewed 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 satisfactory 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.

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Arzerra (ofatumumab) for the treatment of chronic lymphocytic leukaemia (PDF/58.46 KB)


    First published: 11/04/2011
    Last updated: 11/04/2011

  • 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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