EU/3/08/581

About

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Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in December 2018 upon request of the marketing authorisation holder.

The marketing authorisation was withdrawn on 27 February 2019.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
ofatumumab
Medicine name
Arzerra
Disease / condition
Treatment of chronic lymphocytic leukaemia
Date of first decision
07/11/2008
Outcome
Withdrawn
EU designation number
EU/3/08/581

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.

Sponsor's contact details

Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Tel.: +41 (0)61 324 11 11
E-mail: orphan.enquiries@novartis.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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