EU/3/18/2101
Table of contents
About
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.
Key facts
Active substance |
Setmelanotide
|
Disease / condition |
Treatment of leptin receptor deficiency
|
Date of first decision |
19/11/2018
|
Outcome |
Positive
|
EU designation number |
EU/3/18/2101
|
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
Sponsor's contact details
Rhythm Pharmaceuticals Limited
10 Earlsfort Terrace
Dublin 2
D02 T380
Co. Dublin
Ireland
E-mail: regulatory.services@tmcpharma.com
Patients' organisations
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.