EU/3/01/077: Orphan designation for the treatment of short bowel syndrome

[Gly2]-recombinant human glucagon-like peptide

Overview

On 11 December 2001, orphan designation (EU/3/01/077) was granted by the European Commission to Pharm Research Associates (UK) Ltd, United Kingdom, for [gly2]-recombinant human glucagon-like peptide for the treatment of short-bowel syndrome.

The sponsorship was transferred to PAREXEL International Limited, United Kingdom in November 2002 and to Nycomed Danmark ApS, Denmark in April 2008.

In September 2013 Nycomed Danmark ApS changed name to Takeda Pharma A/S.

The sponsorship was transferred to NPS Pharma Holdings Limited, Ireland, in October 2013 and to Shire Pharmaceuticals Ireland Limited, Ireland, in April 2016.

[gly2]-recombinant human glucagon-like peptide has been authorised in the EU as Revestive since 30 August 2012.

The sponsorship was transferred to Takeda Pharmaceuticals International AG Ireland Branch in April 2022.

Key facts

Active substance
[Gly2]-recombinant human glucagon-like peptide
Medicine name
Revestive
Intended use
Treatment of short bowel syndrome
Orphan designation status
Positive
EU designation number
EU/3/01/077
Date of designation
12/12/2001
Sponsor

Takeda Pharmaceuticals International AG Ireland Branch
Block 3 Miesian Plaza
50-58 Baggott Street Lower
Dublin 2
D02 Y754
Co. Dublin
Ireland
Tel: +1 800937970
E-mail: medinfoemea@takeda.com

Review of designation

During its meeting of 10-11 July 2012, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/01/077 for Revestive (teduglutide)1 as an orphan medicinal product for the treatment of short-bowel syndrome. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other satisfactory methods of treatment. The COMP recommended that the orphan designation of the medicine be maintained2.

1 At time of orphan designation teduglutide was known as [gly2]-recombinant human glucagon-like peptide.
2 The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the European Union (EU). This means that in the 10 years after its authorisation, similar products with a comparable therapeutic indication cannot be placed on the market.

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Revestive (teduglutide) for the treatment of short-bowel syndrome (PDF/111.78 KB) (updated)

    Adopted

    First published: 26/09/2012
    Last updated: 09/09/2022
    EMA/COMP/452266/2012

  • 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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