On 16 October 2017, orphan designation (EU/3/17/1923) was granted by the European Commission to Pfizer Limited, United Kingdom, for glasdegib maleate for the treatment of acute myeloid leukaemia.
The sponsorship was transferred to Pfizer Europe MA EEIG, Belgium, in November 2018.
Glasdegib maleate for treatment of acute myeloid leukaemia has been authorised in the EU as Daurismo since 26 June 2020.
Treatment of acute myeloid leukaemia
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Review of designation
Documents related to this orphan designation evaluation
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: