On 17 February 2016, orphan designation (EU/3/16/1609) was granted by the European Commission to Assign Group Development UK Ltd, United Kingdom, for humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s for the treatment of autoimmune haemolytic anaemia.
This medicine is now known as sutimlimab.
The medicinal product has been authorised in the EU as Enjaymo since 15 November 2022.
Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s (sutimlimab)
Treatment of autoimmune haemolytic anaemia
|Orphan designation status||
|EU designation number||
|Date of designation||
Review of designation
|July 2023||The sponsor’s name was changed from Genzyme Europe B.V. to Sanofi B.V. in July 2023.|
|November 2019||The sponsorship was transferred to Genzyme Europe B.V., Netherlands.|
|January 2019||The sponsorship was transferred to Celerion Austria GmbH, Austria.|
|November 2018||The sponsor changed name to Celerion United Kingdom Limited.|
Documents related to this orphan designation evaluation
EU/3/16/1609: Public summary of opinion on orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s for the treatment of autoimmune haemolytic anaemia (PDF/120.89 KB)
First published: 06/04/2016
Last updated: 06/04/2016
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: