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.
Treatment of acute myeloid leukaemia
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Review of designation
Documents related to this orphan designation evaluation
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: