EU/3/01/077

About

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.

Key facts

Active substance
[Gly2]-recombinant human glucagon-like peptide
Medicine name
Revestive
Disease / condition
Treatment of short bowel syndrome
Date of first decision
12/12/2001
Outcome
Positive
EU designation number
EU/3/01/077

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.

Sponsor's contact details

Shire Pharmaceuticals Ireland Limited
Block 2 & 3 Miesian Plaza
50 – 58 Baggot Street Lower
Dublin 2
Ireland
Tel. +353 1429 7700
Fax +353 1429 7701
E-mail: medinfoemea@shire.com

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.

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