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

Table of contents

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.
Winthontlaan 6 N
3526 KV Utrecht
The Netherlands
Tel. +31 302844547
E-mail: medinfo.intl@celgene.com

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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