EU/3/19/2192

About

On 21 August 2019, orphan designation EU/3/19/2192 was granted by the European Commission to TMC Pharma (EU) Limited, Ireland, for setmelanotide for the treatment of Bardet Biedl syndrome.

The sponsorship was transferred to Rhythm Pharmaceuticals Limited, Ireland, in November 2020.

Key facts

Active substance
Setmelanotide
Disease / condition
Treatment of Bardet-Biedl syndrome
Date of first decision
21/08/2019
Outcome
Positive
EU designation number
EU/3/19/2192

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:

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