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)

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.
Paasheuvelweg 25
1105 BP Amsterdam
Noord-Holland
Netherlands
E-mail: eumedinfo.gz@sanofi.com
 

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 PDF icon orphan medicine assessment report

Update history

DateUpdate
July 2023The sponsor’s name was changed from Genzyme Europe B.V. to Sanofi B.V. in July 2023.
November 2019The sponsorship was transferred to Genzyme Europe B.V., Netherlands.
January 2019The sponsorship was transferred to Celerion Austria GmbH, Austria.
November 2018The sponsor changed name to Celerion United Kingdom Limited.

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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