EU/3/16/1688: Orphan designation for the treatment of Prader-Willi syndrome

Setmelanotide

Table of contents

Overview

On 27 June 2016, orphan designation (EU/3/16/1688) was granted by the European Commission to TMC Pharma Services Ltd, United Kingdom, for setmelanotide for the treatment of Prader-Willi syndrome.

Key facts

Active substance
Setmelanotide
Intended use
Treatment of Prader-Willi syndrome
Orphan designation status
Positive
EU designation number
EU/3/16/1688
Date of designation
27/06/2016
Sponsor

Rhythm Pharmaceuticals Netherlands B.V.
Radarweg 29
1043 NX Amsterdam
Noord-Holland
Netherlands
tel: +31 20 854 6071
e-mail: RhythmRegulatory@rhythmtx.com

Update history

Date Update
July 2022 The sponsor's address was updated.
October 2021 The sponsorship was transferred to Rhythm Pharmaceuticals Netherlands B.V. in October 2021.
November 2020 The sponsorship was transferred to Rhythm Pharmaceuticals Limited, Ireland, in November 2020.
March 2019 The sponsorship was transferred to TMC Pharma (EU) Limited, Ireland, in March 2019.

Documents related to this orphan designation evaluation

Patients' organisations

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.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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