EU/3/16/1756: Orphan designation for the treatment of cutaneous T-cell lymphoma
Table of contents
On 14 October 2016, orphan designation (EU/3/16/1756) was granted by the European Commission to Kyowa Kirin Limited, United Kingdom, for mogamulizumab for the treatment of cutaneous T-cell lymphoma.
The sponsorship was transferred to Kyowa Kirin Holdings B.V., The Netherlands, in August 2018.
Mogamulizumab has been authorised in the EU as Poteligeo since 22 November 2018.
Treatment of cutaneous T-cell lymphoma
|Orphan designation status||
|EU designation number||
|Date of designation||
Kyowa Kirin Holdings B.V.
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Poteligeo 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 .
Documents related to this orphan designation evaluation
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: