EU/3/10/784

About

Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in October 2015 on request of the sponsor.

On 20 September 2010, orphan designation (EU/3/10/784) was granted by the European Commission to Inspiration Biopharmaceuticals EU Limited, Ireland, for recombinant porcine factor VIII (B-domain-deleted) for the treatment of haemophilia A.

The sponsorship was transferred to Baxter Innovations GmbH, Austria, in July 2013.

In May 2015, Baxter Innovations GmbH changed name to Baxalta Innovations GmbH.

Key facts

Active substance
Recombinant porcine factor VIII (B-domain-deleted)
Medicine name
Obizur
Disease / condition
Treatment of haemophilia A
Date of decision
20/09/2010
Outcome
Withdrawn
Orphan decision number
EU/3/10/784

Review of designation

Please note that this product (marketed as Obizur) was withdrawn from the Community Register of designated orphan medicinal products in October at the request of the sponsor, at the time of the granting of a marketing authorisation.


During its meeting of 6 to 8 October 2015, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/10/784 for Obizur (susoctocog alfa1) as an orphan medicinal product in the treatment of haemophilia A. 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 A. As one of the criteria for orphan designation is no longer met (i.e. the significant benefit), the COMP recommended that the orphan designation of the product should not be maintained2.


1Previously known as recombinant porcine factor VIII (B-domain-deleted).
2The removal of the orphan designation at time of marketing authorisation means that the product cannot benefit from 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with a comparable therapeutic indication can be placed on the market.

Sponsor's contact details

Baxalta Innovations GmbH
Industriestrasse 67
A-1221 Vienna
Austria
Tel. +43 1 201002472542
Fax +43 1 201002475990
E-mail: europe_biosci_globalra@baxalta.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.

How useful was this page?

Add your rating