EU/3/16/1701:

poly(oxy-1,2-ethanediyl), alpha-(carboxymethyl)-omega-methoxy-, amide with arginase 1 [cobalt cofactor] (synthetic human) (1:10), trimer (pegzilarginase)

Overview

This medicine is now known as pegzilarginase.

On 14 July 2016, orphan designation (EU/3/16/1701) was granted by the European Commission to ERA Consulting GmbH, Germany, for poly(oxy-1,2-ethanediyl), alpha-(carboxymethyl)-omega-methoxy-, amide with arginase 1 [cobalt cofactor] (synthetic human) (1:10), trimer (also known as AEB1102) for the treatment of hyperargininaemia.

The sponsorship was transferred to YES Pharmaceutical Development Services GmbH, Germany, in August 2021.

Key facts

Active substance
poly(oxy-1,2-ethanediyl), alpha-(carboxymethyl)-omega-methoxy-, amide with arginase 1 [cobalt cofactor] (synthetic human) (1:10), trimer (pegzilarginase)
Intented use
Treatment of hyperargininaemia
Orphan designation status
Positive
EU designation number
EU/3/16/1701
Date of designation
14/07/2016
Sponsor

YES Pharmaceutical Development Services GmbH
Bahnstrasse 42-46
61381 Friedrichsdorf
Hassia
Germany
Tel. +49 6172 764 64 65
E-mail: PParsonson@aegleabio.com 

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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