EU/3/13/1125: Orphan designation for the treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma

(S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one (duvelisib)


On 26 April 2013, orphan designation (EU/3/13/1125) was granted by the European Commission to Voisin Consulting S.A.R.L, France, for (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one (duvelisib) for the treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma.

The sponsorship was transferred to Abbvie Ltd, United Kingdom, in November 2015, then to Voisin Consulting S.A.R.L., France, in September 2016 and finally to Verastem Europe GmbH, Germany, in November 2019.

This medicine is now known as duvelisib.

Please note that this product (marketed as Copiktra) was withdrawn from the Union Register of orphan medicinal products in March 2021 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.

Key facts

Active substance
(S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one (duvelisib)
Intended use
Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma
Orphan designation status
EU designation number
Date of designation

Verastem Europe GmbH
Lange Strasse 70
Lower Saxony 29664

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one at the time of marketing authorisation

The sponsor formally requested the withdrawal of the orphan designation prior to the Committee’s final opinion. More information is available in the withdrawal assessment report – orphan maintenance.

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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