EU/3/16/1826: Orphan designation for the prevention of graft rejection following solid organ transplantation
Recombinant IgG degrading enzyme of Streptococcus pyogenes (imlifidase)
Table of contents
Overview
This medicine is now known as imlifidase.
On 12 January 2017, orphan designation (EU/3/16/1826) was granted by the European Commission to Hansa Medical AB, Sweden, for recombinant IgG degrading enzyme of Streptococcus pyogenes (also known as HMED-Ides) for the prevention of graft rejection following solid organ transplantation.
In February, Hansa Medical AB changed name to Hansa Biopharma AB.
Recombinant IgG degrading enzyme of Streptococcus pyogenes has been authorised in the EU as Idefirix since 25 August 2020.
Key facts
Active substance |
Recombinant IgG degrading enzyme of Streptococcus pyogenes (imlifidase)
|
Medicine name |
Idefirix
|
Intended use |
Prevention of graft rejection following solid organ transplantation
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/16/1826
|
Date of designation |
12/01/2017
|
Sponsor |
Hansa Biopharma AB |
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Idefirix at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.
More information is available in the
orphan medicine assessment report
.
Patients' organisations
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: