EU/3/18/2057: Orphan designation for the treatment of acute myeloid leukaemia

1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt (onvansertib)

Overview

Please note that this product was withdrawn from the Union Register of orphan medicinal products in November 2022 on request of the Sponsor.

On 24 August 2018, orphan designation (EU/3/18/2057) was granted by the European Commission to Pharm Research Associates (UK) Limited, United Kingdom, for 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt (also known as PCM-075) for the treatment of acute myeloid leukaemia.

 

Key facts

Active substance
1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt (onvansertib)
Intended use
Treatment of acute myeloid leukaemia
Orphan designation status
Withdrawn
EU designation number
EU/3/18/2057
Date of designation
24/08/2018
Sponsor

Pharmaceutical Research Associates Group B.V.
Van Swietenlaan 6
9728 NZ Groningen
Netherlands
Tel: +31 50 402 2222
E-mail: PRARegulatoryAffairs@prahs.com

Review of designation

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

Update history

DateUpdate
November 2022Product withdrawn from the Union Register of orphan medicinal products on request of the Sponsor.
May 2019The sponsorship was transferred to Pharmaceutical Research Associates Group B.V., The Netherlands.

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • 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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