EU/3/16/1802: Orphan designation for the treatment of acute myeloid leukaemia



On 12 December 2016, orphan designation (EU/3/16/1802) was granted by the European Commission to QRC Consultants Ltd, United Kingdom, for ivosidenib for the treatment of acute myeloid leukaemia.

The sponsorship was transferred: 

  • to Quality Regulatory Clinical Ireland Limited, Ireland, in June 2018;
  • to FGK Representative Service GmbH, Germany in December 2018; 
  • to Agios Netherlands B.V., Netherlands, in November 2019 and
  • to Les Laboratoires Servier, France, in June 2021.

Key facts

Active substance
Intended use
Treatment of acute myeloid leukaemia
Orphan designation status
EU designation number
Date of designation

Les Laboratoires Servier
50 rue Carnot
92284 Suresnes Cedex
Tel. +33 1 55 72 60 00
E-mail :

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Documents related to this orphan designation evaluation

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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