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.
recombinant human interleukin-3 truncated diphtheria toxin fusion protein
Treatment of acute myeloid leukaemia
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Review of designation
Documents related to this orphan designation evaluation
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: