EU/3/16/1680: Orphan designation for the treatment of neuromyelitis optica spectrum disorders
Humanised anti-IL-6 receptor monoclonal antibody (satralizumab)
Table of contents
Overview
This medicine is now known as satralizumab.
On 27 June 2016, orphan designation (EU/3/16/1680) was granted by the European Commission to Chugai Pharma Europe Ltd, UK, for humanised anti-IL-6 receptor monoclonal antibody (also known as SA237) for the treatment of neuromyelitis optica spectrum disorders.
The sponsorship was transferred to Chugai Pharma France, France, in January 2019.
The sponsorship was transferred to Roche Registration GmbH, Germany, in August 2019.
The medicinal product has been authorised in the EU as Enspryng since 24 June 2021.
Key facts
Active substance |
Humanised anti-IL-6 receptor monoclonal antibody (satralizumab)
|
Intended use |
Treatment of neuromyelitis optica spectrum disorders
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/16/1680
|
Date of designation |
27/06/2016
|
Sponsor |
Roche Registration GmbH |
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Enspryng (humanised anti-IL-6 receptor monoclonal antibody) 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.
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: