EU/3/13/1125

About

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.

Key facts

Active substance
(S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one (duvelisib)
Disease / condition
Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma
Date of first decision
26/04/2013
Outcome
Positive
EU designation number
EU/3/13/1125

Review of designation

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

Sponsor's contact details

Verastem Europe GmbH
Lange Strasse 70
Walsrode
Lower Saxony 29664
Germany

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;

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