EU/3/13/1210: Orphan designation for the treatment of hypoparathyroidism

Recombinant human parathyroid hormone

Overview

On 16 January 2014, orphan designation (EU/3/13/1210) was granted by the European Commission to NPS Pharma UK Ltd, United Kingdom, for recombinant human parathyroid hormone for the treatment of hypoparathyroidism.

The sponsorship was transferred to Shire Pharmaceuticals Ireland Limited, Ireland, in January 2016.

Recombinant human parathyroid hormone has been authorised in the EU as Natpar since 24 April 2017.

The sponsorship was transferred to Takeda Pharmaceuticals International AG Ireland Branch in September 2021.

Key facts

Active substance
Recombinant human parathyroid hormone
Intended use
Treatment of hypoparathyroidism
Orphan designation status
Positive
EU designation number
EU/3/13/1210
Date of designation
16/01/2014
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

On 6 March 2017, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/13/1210 for Natpar (parathyroid hormone) as an orphan medicinal product for the treatment of hypoparathyroidism. 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 methods of treatment. As other methods of treatment are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with treatment of hypoparathyroidism. The COMP recommended that the orphan designation of the medicine be maintained1


1 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 EU. This means that in the 10 years after its authorisation similar products with the same 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 : Natpar (parathyroid hormone) for the treatment of hypoparathyroidism (PDF/80.68 KB)


    First published: 26/04/2017
    Last updated: 26/04/2017
    EMA/172380/2017

  • 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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