EU/3/17/1961

About

On 17 January 2018, orphan designation (EU/3/17/1961) was granted by the European Commission to Astellas Pharma Europe B.V., the Netherlands, for gilteritinib (also known as ASP2215) for the treatment of acute myeloid leukaemia.

Xospata for treatment of acute myeloid leukaemia has been authorised in the EU as Xospata since 2019. 

Key facts

Active substance
Gilteritinib
Disease / condition
Treatment of acute myeloid leukaemia
Date of first decision
17/01/2018
Outcome
Positive
EU designation number
EU/3/17/1961

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Xospata 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

Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
The Netherlands
Tel. +31 7154 55878
E-mail: contact@nl.astellas.com

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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