EU/3/07/453

About

On 8 June 2007, orphan designation (EU/3/07/453) was granted by the European Commission to Biovitrum AB, Sweden, for recombinant fusion protein consisting of human coagulation factor IX attached to the Fc domain of human IgG1 for the treatment of haemophilia B (congenital factor IX deficiency).

The sponsorship was transferred to Biogen Idec Limited, United Kingdom, in August 2010.

Update: recombinant fusion protein consisting of human coagulation factor IX attached to the Fc domain of human IgG1 has been authorised in the EU as Alprolix since 12 May 2016.

Key facts

Active substance
Recombinant fusion protein consisting of human coagulation factor IX attached to the Fc domain of human IgG1
Medicine name
Alprolix
Disease / condition
Treatment of haemophilia B (congenital factor IX deficiency)
Date of decision
08/06/2007
Outcome
Positive
Orphan decision number
EU/3/07/453

Review of designation

During its meeting of 21 to 23 March 2016, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/07/453 for Alprolix (eftrenonacog 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.


1 Previously known as recombinant fusion protein consisting of human coagulation factor IX attached to the Fc domain of human IgG1.

2 The 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

Biogen Idec Limited
Innovation House
70 Norden Road
Maidenhead
Berkshire, SL6 4AY
United Kingdom
Tel. +44(0) 1628 501 000
E-mail: ukreception@biogenidec.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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