EU/3/09/622: Orphan designation for the treatment of acute myeloid leukaemia

N-(5-tert-Butylisoxazol-3-yl)-N'-{4-[7-(2-(morpholin-4-yl)ethoxy) imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea di-hydrochloride salt

Table of contents

Overview

On 23 March 2009, orphan designation (EU/3/09/622) was granted by the European Commission to Ambit Europe Limited, United Kingdom, for N-(5-tert-Butylisoxazol-3-yl)-N'-{4-[7-(2-(morpholin-4-yl)ethoxy) imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea di-hydrochloride salt for the treatment of acute myeloid leukaemia.

The sponsorship was transferred to Daiichi Sankyo Development Ltd, United Kingdom, in June 2016.

Key facts

Active substance
N-(5-tert-Butylisoxazol-3-yl)-N'-{4-[7-(2-(morpholin-4-yl)ethoxy) imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea di-hydrochloride salt
Intended use
Treatment of acute myeloid leukaemia
Orphan designation status
Positive
EU designation number
EU/3/09/622
Date of designation
23/03/2009
Sponsor
Daiichi Sankyo Development Ltd
Chiltern Place
Chalfont Park
Gerrards Cross
Buckinghamshire SL9 0BG
United Kingdom
Tel. +44 (0)1753 482 813
Fax +44 (0)1753 899 107
E-mail: info@dsd-eu.com

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:

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