On 5 February 2002, orphan designation (EU/3/01/082) was granted by the European Commission to ILEX Services Limited, United Kingdom, for 2-chloro-9-[2-deoxy-2-fluoro-ß-D-arabinofuranosyl]adenine for the treatment of acute lymphoblastic leukaemia (ALL).
The sponsorship was transferred to Bioenvision, United Kingdom, in December 2002 and subsequently to Genzyme Europe BV, The Netherlands, in May 2008.
Update: 2-chloro-9-[2-deoxy-2-fluoro-ß-D-arabinofuranosyl]adenine has been authorised in the European Union as Evoltra since 29 May 2006.
Treatment of acute lymphoblastic leukaemia
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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: