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.
Recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23 (burosumab)
|Disease / condition||
Treatment of X-linked hypophosphataemia
|Date of decision||
|Orphan decision number||
Review of designation
Sponsor's contact details
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;