Setmelanotide has been authorised in the EU as Imcivree since 16 July 2021.
On 14 July 2016, orphan designation (EU/3/16/1703) was granted by the European Commission to TMC Pharma Services Ltd, United Kingdom, for setmelanotide for the treatment of pro-opiomelanocortin deficiency.
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.
Treatment of pro-opiomelanocortin deficiency
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Review of designation
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.