EU/3/16/1680: Orphan designation for the treatment of neuromyelitis optica spectrum disorders

Humanised anti-IL-6 receptor monoclonal antibody (satralizumab)

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
Emil-Barell-Strasse 1
Grenzach
79639 Grenzach-Wyhlen
Germany
E-mail: info.orphan@roche.com

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.

Documents related to this orphan designation evaluation

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:

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