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.
The sponsorship was transferred to Clinical Network Services (NL) BV, The Netherlands, in February 2019.
In August 2020, Clinical Network Services (NL) B.V.changed name to Scendea (NL) B.V.
Recombinant human monoclonal antibody to insulin receptor
|Disease / condition||
Treatment of congenital hyperinsulinism
|Date of first decision||
|EU designation number||
Review of designation
Sponsor's contact details
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.