EU/3/18/1974: Orphan designation for the treatment of acute myeloid leukaemia

6-{[(1R,2S)-2-aminocyclohexyl]amino}-7-fluoro-4-(1-methyl-1H-pyrazol-4-yl)-1,2-dihydro-3H-pyrrolo[3,4-c]pyridin-3-one monocitrate (also known as mivavotinib)

Table of contents

Overview

On 22 February 2018, orphan designation (EU/3/18/1974) was granted by the European Commission to Takeda Pharma A/S, Denmark, for 6-{[(1R,2S)-2-aminocyclohexyl]amino}-7-fluoro-4-(1-methyl-1H-pyrazol-4-yl)-1,2-dihydro-3H-pyrrolo[3,4-c]pyridin-3-one monocitrate (also known as mivavotinib) for the treatment of acute myeloid leukaemia.

 

Key facts

Active substance
6-{[(1R,2S)-2-aminocyclohexyl]amino}-7-fluoro-4-(1-methyl-1H-pyrazol-4-yl)-1,2-dihydro-3H-pyrrolo[3,4-c]pyridin-3-one monocitrate (also known as mivavotinib)
Intended use
Treatment of acute myeloid leukaemia
Orphan designation status
Positive
EU designation number
EU/3/18/1974
Date of designation
22/02/2018
Sponsor

Calithera Biosciences Ireland Limited
88 Harcourt Street
Dublin 2
DO2 DK18
Co. Dublin
Ireland
Tel. +353 1 691 5835
E-mail: EUCalithera@calithera.com

Update history

DateUpdate
May 2022The sponsorship was transferred to Calithera Biosciences Ireland Limited, Ireland in May 2022. 
August 2020The sponsor's address was updated in August 2020
 

 

 

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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