Setmelanotide has been authorised in the EU as Imcivree since 16 July 2021.
On 19 November 2018, orphan designation (EU/3/18/2101) was granted by the European Commission to TMC Pharma Services Ltd, United Kingdom, for setmelanotide for the treatment of leptin receptor 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 leptin receptor 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:
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.