EU/3/16/1802: Orphan designation for the treatment of acute myeloid leukaemia
Table of contents
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.
Ivosidenib for treatment of acute myeloid leukaemia has been authorised in the EU as Tibsovo since 4 May 2023.
Treatment of acute myeloid leukaemia
|Orphan designation status||
|EU designation number||
|Date of designation||
Les Laboratoires Servier
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Tibsovo at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.
More information is available in the orphan medicine assessment report .
|June 2021||The sponsorship was transferred to Les Laboratoires Servier, France.|
|November 2019||The sponsorship was transferred to Agios Netherlands B.V., Netherlands.|
|December 2018||The sponsorship was transferred to FGK Representative Service GmbH, Germany.|
|June 2018||The sponsorship was transferred to Quality Regulatory Clinical Ireland Limited, Ireland.|
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: