EU/3/16/1702: Orphan designation for the treatment of congenital hyperinsulinism

Recombinant human monoclonal antibody to insulin receptor


On 14 July 2016, orphan designation (EU/3/16/1702) was granted by the European Commission to XOMA UK Limited, United Kingdom, for the recombinant human monoclonal antibody to insulin receptor (also known as XOMA 358) for the treatment of congenital hyperinsulinism.

Key facts

Active substance
Recombinant human monoclonal antibody to insulin receptor
Intended use
Treatment of congenital hyperinsulinism
Orphan designation status
EU designation number
Date of designation

Rezolute (Bio) Ireland Limited
Riverside Two
Sir John Rogerson's Quay
Dublin 2
Dublin D02

Review of designation

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

Update history

June 2022The sponsorship was transferred to Rezolute (Bio) Ireland Limited, Ireland in June 2022
August 2020In August 2020, Clinical Network Services (NL) B.V.changed name to Scendea (NL) B.V. 
February 2019The sponsorship was transferred to Clinical Network Services (NL) BV, The Netherlands, in February 2019.

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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