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.

Key facts

Active substance
Recombinant human monoclonal antibody to insulin receptor
Disease / condition
Treatment of congenital hyperinsulinism
Date of first decision
EU designation number

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

Scendea (NL) B.V.
De Cuserstraat 93
1081 CN Amsterdam
Tel. +31 2089 49169

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.

How useful was this page?

Add your rating