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.

Ivosidenib for treatment of acute myeloid leukaemia has been authorised in the EU as Tibsovo since 4 May 2023.

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 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 PDF icon orphan medicine assessment report .

Update history

June 2021The sponsorship was transferred to Les Laboratoires Servier, France.
November 2019The sponsorship was transferred to Agios Netherlands B.V., Netherlands.
December 2018The sponsorship was transferred to FGK Representative Service GmbH, Germany.
June 2018The sponsorship was transferred to Quality Regulatory Clinical Ireland Limited, Ireland. 

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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