On 27 June 2016, orphan designation (EU/3/16/1688) was granted by the European Commission to TMC Pharma Services Ltd, United Kingdom, for setmelanotide for the treatment of Prader-Willi syndrome.
The sponsorship was transferred to TMC Pharma (EU) Limited, Ireland, in March 2019.
The sponsorship was transferred to Rhythm Pharmaceuticals Limited, Ireland, in November 2020.
|Disease / condition||
Treatment of Prader-Willi syndrome
|Date of first decision||
|EU designation number||
Sponsor's contact details
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.