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 |
Update history
Date | Update |
---|---|
May 2022 | The sponsorship was transferred to Calithera Biosciences Ireland Limited, Ireland in May 2022. |
August 2020 | The sponsor's address was updated in August 2020 |
|
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: