EU/3/16/1609: Orphan designation for the treatment of autoimmune haemolytic anaemia
Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s (sutimlimab)
Table of contents
Overview
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.
Key facts
Active substance |
Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s (sutimlimab)
|
Intended use |
Treatment of autoimmune haemolytic anaemia
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/16/1609
|
Date of designation |
17/02/2016
|
Sponsor |
Sanofi B.V. |
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Enjaymo at the time of marketing authorisation, and confirmed that the orphan designation should be maintained. More information is available in the
orphan medicine assessment report
Update history
Date | Update |
---|---|
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. |
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: