On 4 February 2010, orphan designation (EU/3/09/723) was granted by the European Commission to CSL Behring GmbH, Germany, for recombinant fusion protein linking human coagulation factor IX with human albumin (also known as rIX-FP) for the treatment of haemophilia B.
Update: recombinant fusion protein linking human coagulation factor IX with human albumin has been authorised in the EU as Idelvion since 11 May 2016.
Recombinant fusion protein linking human coagulation factor IX with human albumin
Treatment of haemophilia B
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Review of designation
During its meeting of 21 to 23 March 2016, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/09/723 for Idelvion (albutrepenonacog alfa1) as an orphan medicinal product for the treatment of haemophilia B. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other methods of treatment. As other methods of treatment are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with haemophilia B. The COMP recommended that the orphan designation of the medicine be maintained2.
1Previously known as recombinant fusion protein linking human coagulation factor IX with human albumin.
2The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with the same therapeutic indication cannot be placed on the market.
Documents related to this orphan designation evaluation
Recommendation for maintenance of orphan designation at the time of marketing authorisation: Idelvion (albutrepenonacog alfa) for the treatment of haemophilia B (PDF/79.15 KB)
First published: 31/05/2016
Last updated: 31/05/2016
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
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: