EU/3/15/1567:

recombinant human interleukin-3 truncated diphtheria toxin fusion protein

Overview

On 11 November 2015, orphan designation (EU/3/15/1567) was granted by the European Commission to Spector Consulting SAS, France, for recombinant human interleukin-3 truncated diphtheria toxin fusion protein (also known as SL-401) for the treatment of blastic plasmacytoid dendritic cell neoplasm.

The sponsorship was transferred to TMC Pharma (EU) Limited, Ireland, in November 2018 and to Stemline Therapeutics B.V. in November 2019.

Recombinant human interleukin-3 truncated diphtheria toxin fusion protein has been authorised in the EU as Elzonris since 7 January 2021.

Key facts

Active substance
recombinant human interleukin-3 truncated diphtheria toxin fusion protein
Intented use
Treatment of blastic plasmacytoid dendritic cell neoplasm
Date of designation
11/11/2015
Orphan designation status
Positive
EU designation number
EU/3/15/1567

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of product 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 .

Sponsor's contact details

Stemline Therapeutics B.V.
Prins Bernhardplein 200
1097 JB Amsterdam 
Noord-Holland
Netherlands
Tel. + 31 20 521 4988
E-mail: EUmedinfo@stemline.com
 

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.

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