EU/3/09/723

About

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.

More information on Idelvion can be found in the European public assessment report (EPAR).

Key facts

Active substance
Recombinant fusion protein linking human coagulation factor IX with human albumin
Disease / condition
Treatment of haemophilia B
Date of first decision
04/02/2010
Outcome
Positive
EU designation number
EU/3/09/723

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.

Sponsor's contact details

CSL Behring GmbH
Emil-von-Behring-Str. 76
35041 Marburg
Germany
Tel. +49 6421 3912
Fax +49 6421 3985
E-mail: EU-CSLBehring@cslbehring.com

Patients' organisations

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.

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