EU/3/17/1961: Orphan designation for the treatment of acute myeloid leukaemia



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
Intended use
Treatment of acute myeloid leukaemia
Orphan designation status
EU designation number
Date of designation
Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
The Netherlands
Tel. +31 7154 55878

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 icon orphan medicine assessment report

Documents related to this orphan designation evaluation

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:

Related content

How useful was this page?

Add your rating
1 rating