EU/3/17/1961: Orphan designation for the treatment of acute myeloid leukaemia
Gilteritinib
Table of contents
Overview
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
|
Intended use |
Treatment of acute myeloid leukaemia
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/17/1961
|
Date of designation |
17/01/2018
|
Sponsor |
Astellas Pharma Europe B.V.
Sylviusweg 62 2333 BE Leiden The Netherlands Tel. +31 7154 55878 E-mail: contact@nl.astellas.com |
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
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: