EU/3/14/1409: Orphan designation for the treatment of malignant mesothelioma

Pegylated recombinant arginine deiminase (pegargiminase)


On 15 January 2015, orphan designation (EU/3/14/1409) was granted by the European Commission to Designerx Europe Limited, United Kingdom, for pegylated recombinant arginine deiminase for the treatment of malignant mesothelioma.

The sponsorship was transferred to Polaris Pharmaceuticals Ireland Limited, Ireland, in March 2019.

Key facts

Active substance
Pegylated recombinant arginine deiminase (pegargiminase)
Intended use
Treatment of malignant mesothelioma
Orphan designation status
EU designation number
Date of designation

Polaris Pharmaceuticals Ireland Limited
88 Harcourt Street
Dublin 2 D02 DK18

Tel: +353 1541 4798

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

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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