EU/3/16/1721

About

On 29 August 2016, orphan designation (EU/3/16/1721) was granted by the European Commission to Araim Pharma Europe Ltd, United Kingdom, for L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser (also known as ARA 290) for the prevention of graft loss in pancreatic islet transplantation.

This medicine is now known as cibinetide.

The sponsorship was transferred to Araim Pharmaceuticals Europe Limited, Ireland, in April 2019.

Key facts

Active substance
L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser (cibinetide)
Disease / condition
Prevention of graft loss in pancreatic islet transplantation
Date of decision
29/08/2016
Outcome
Positive
Orphan decision number
EU/3/16/1721

Review of designation


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

Sponsor's contact details

Araim Pharmaceuticals Europe Limited
Riverside One
Sir John Rogerson's Quay
Dublin 2
D02 X576
Ireland
Tel.:  +353 1 829 0000
E-mail: info@araimpharma.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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