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.
Recombinant human monoclonal antibody to insulin receptor
Treatment of congenital hyperinsulinism
|Orphan designation status||
|EU designation number||
|Date of designation||
Review of designation
|June 2022||The sponsorship was transferred to Rezolute (Bio) Ireland Limited, Ireland in June 2022|
|August 2020||In August 2020, Clinical Network Services (NL) B.V.changed name to Scendea (NL) B.V.|
|February 2019||The sponsorship was transferred to Clinical Network Services (NL) BV, The Netherlands, in February 2019.|
Documents related to this orphan designation evaluation
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: