EU/3/18/1994: Orphan designation for the treatment of biliary tract cancer

Ivosidenib

Overview

On 21 March 2018, orphan designation (EU/3/18/1994) was granted by the European Commission to QRC Consultants Ltd, United Kingdom, for ivosidenib for the treatment of biliary tract cancer.

The sponsorship was transferred: 

  • to Quality Regulatory Clinical Ireland Limited, Ireland, in August 2018;
  • to Agios Netherlands B.V., Netherlands in December 2020 and 
  • to Les Laboratoires Servier, France, in June 2021.

Key facts

Active substance
Ivosidenib
Intended use
Treatment of biliary tract cancer
Orphan designation status
Positive
EU designation number
EU/3/18/1994
Date of designation
21/03/2018
Sponsor

Les Laboratoires Servier
50 rue Carnot
92284 Suresnes Cedex
France
Tel. +33 1 55 72 60 00
E-mail : mail.odd.enquiries@servier.com

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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