EU/3/14/1351

About

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
Disease / condition
Treatment of X-linked hypophosphataemia
Date of decision
14/10/2014
Outcome
Positive
Orphan decision number
EU/3/14/1351

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 PDF iconorphan medicine assessment report .

Sponsor's contact details

Kyowa Kirin Holdings B.V.
Bloemlaan 2
2132NP Hoofddorp
E-mail: medinfo@kyowakirin.com
The Netherlands

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;

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