EU/3/15/1563: Orphan designation for the treatment of acute myeloid leukaemia

recombinant human interleukin-3 truncated diphtheria toxin fusion protein

Overview

On 9 October 2015, orphan designation (EU/3/15/1563) 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 acute myeloid leukaemia.

The sponsorship was transferred to TMC Pharma (EU) Limited, Ireland, in February 2019.

The sponsorship was transferred to Stemline Therapeutics B.V. in November 2019.

The sponsor’s address was updated in April 2022.

Key facts

Active substance
recombinant human interleukin-3 truncated diphtheria toxin fusion protein
Intended use
Treatment of acute myeloid leukaemia
Orphan designation status
Positive
EU designation number
EU/3/15/1563
Date of designation
09/10/2015
Sponsor

Stemline Therapeutics B.V.
Basisweg 10
1043 AP Amsterdam 
Noord-Holland
Netherlands
Tel. + 31 20 521 4988
E-mail: EUmedinfo@stemline.com
 

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

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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