EU/3/14/1351: Orphan designation for the treatment of X-linked hypophosphataemia
Recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23 (burosumab)
Table of contents
Overview
This medicine is now known as burosumab.
On 15 October 2014, orphan designation (EU/3/14/1351) was granted by the European Commission to NDA Group AB, Sweden, for recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23 for the treatment of X-linked hypophosphataemia.
Recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23 for the treatment of X-linked hypophosphataemia has been authorised in the EU as Crysvita since 19 February 2018.
The sponsorship was transferred to Kyowa Kirin Holdings B.V., The Netherlands, in July 2018.
Key facts
Active substance |
Recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23 (burosumab)
|
Medicine name |
Crysvita
|
Intended use |
Treatment of X-linked hypophosphataemia
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/14/1351
|
Date of designation |
15/10/2014
|
Sponsor |
Kyowa Kirin Holdings B.V. |
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Crysvita 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: