This medicine is now known as dalcinonacog alfa.
On 20 June 2017, orphan designation (EU/3/17/1884) was granted by the European Commission to Voisin Consulting S.A.R.L., France, for recombinant human factor IX protein modified with three point mutations (also known as CB 2679d or ISU304) for the treatment of haemophilia B.
Recombinant human factor IX protein modified with three point mutations (dalcinonacog alfa)
Treatment of haemophilia B
|Orphan designation status||
|EU designation number||
|Date of designation||
Review of designation
|August 2023||The sponsorship was transferred to Premier Research Group S.L., Spain in August 2023.|
|July 2020||The sponsorship was transferred to Turnkey PharmaConsulting Ireland Limited, Ireland.|
|October 2019||The sponsorship was transferred to Regintel Limited, Ireland.|
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: