EU/3/18/2101:

Setmelanotide

Overview

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.

Key facts

Active substance
Setmelanotide
Intented use
Treatment of leptin receptor deficiency
Date of designation
19/11/2018
Orphan designation status
Positive
EU designation number
EU/3/18/2101

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Imcivree 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.

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.

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