EU/3/05/328: Orphan designation for the treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)
(E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone
Overview
On 28 October 2005, orphan designation (EU/3/05/328) was granted by the European Commission to The Matthews Consultancy Ltd, United Kingdom, for (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23-tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone (also known as “depsipeptide”) for the for the treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated).
The sponsorship was transferred to Gloucester Pharmaceuticals Limited, United Kingdom, in October 2008 and to Celgene Europe Limited, United Kingdom, in September 2010. The sponsorship was transferred to Celgene Europe B.V., The Netherlands, in September 2018.
Key facts
Active substance |
(E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone
|
Intended use |
Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/05/328
|
Date of designation |
28/10/2005
|
Sponsor |
Celgene Europe B.V. |
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: