EU/3/19/2227: Orphan designation for the treatment of tenosynovial giant cell tumour, localised and diffuse type

2-(isopropylamino)-3-methyl-5-(6-methyl-5-((2-(1-methyl-1H-pyrazol-4-yl)pyridin-4-yl)oxy)pyridin-2-yl)pyrimidin-4(3H)-one

Overview

On 16 December 2019, orphan designation EU/3/19/2227 was granted by the European Commission to Pharma Gateway AB, Sweden, for 2-(isopropylamino)-3-methyl-5-(6-methyl-5-((2-(1-methyl-1H-pyrazol-4-yl)pyridin-4-yl)oxy)pyridin-2-yl)pyrimidin-4(3H)-one (also known as DCC-3014) for the treatment of tenosynovial giant cell tumour, localised and diffuse type.

The sponsorship was transferred to Deciphera Pharmaceuticals (Netherlands) B.V., Netherlands, in July 2020.

The sponsor’s address was updated in August 2021.

Key facts

Active substance
2-(isopropylamino)-3-methyl-5-(6-methyl-5-((2-(1-methyl-1H-pyrazol-4-yl)pyridin-4-yl)oxy)pyridin-2-yl)pyrimidin-4(3H)-one
Intended use
Treatment of tenosynovial giant cell tumour, localised and diffuse type
Orphan designation status
Positive
EU designation number
EU/3/19/2227
Date of designation
16/12/2019
Sponsor

Deciphera Pharmaceuticals (Netherlands) B.V.
Atrium Building Floor 4th
Strawinskylaan 3051
Amsterdam
Noord-Holland
1077 ZX
Netherlands
Tel: +31 20 301 2200
E-mail: regulatory@deciphera.com

 

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

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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