EU/3/16/1627: Orphan designation for the treatment of post-transplantation lymphoproliferative disorders

Allogeneic Epstein-Barr virus specific cytotoxic T lymphocytes (Tabelecleucel)

Overview

On 21 March 2016, orphan designation (EU/3/16/1627) was granted by the European Commission to Wainwright Associates Ltd, United Kingdom, for allogeneic Epstein-Barr virus specific cytotoxic T lymphocytes for the treatment of post-transplant lymphoproliferative disorder.

In November 2016 sponsor, Wainwright Associates Ltd changed name to PharmaLex UK Services Limited.

The sponsorship was transferred to Atara Biotherapeutics Ireland Limited, Ireland, in February 2017.

The medicinal product has been authorised in the EU as Kinpeygo since 16 December 2022

Key facts

Active substance
Allogeneic Epstein-Barr virus specific cytotoxic T lymphocytes (Tabelecleucel)
Intended use
Treatment of post-transplantation lymphoproliferative disorders
Orphan designation status
Positive
EU designation number
EU/3/16/1627
Date of designation
21/03/2016
Sponsor

Pierre Fabre Medicament
Les Cauquillous
81500 Lavaur
France
Email: sophie.blanchet@pierre-fabre.com

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

The Committee for Orphan Medicinal Products reviewed the orphan designation of Ebvallo 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.

Update history

DateUpdate
January 2023The sponsorship was transferred from Atara Biotherapeutics Ireland Limited to Pierre Fabre Medicament, France.

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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