On 24th April 2017, it was announced that the Idis Managed Access division of Clinigen Group and Onxeo have agreed to launch a Managed Access program for belinostat (marketed as BELEODAQ® in the U.S.) in Europe.
The program will allow physicians to request belinostat for specific patients for whom alternative treatment options are not currently available. On a named patient basis, this will allow access to belinostat ahead of a potential EU approval. The program will be available in 13 European countries: France, Spain, Germany, Belgium, Italy, The United Kingdom, Luxembourg, Austria, Denmark, Sweden, Norway, Finland, and The Netherlands.
Belinostat is a HDAC inhibitor used to treat R/R PTCL and in July 2014 received accelerated approval by the U.S. Food and Drug Administration (FDA) in this indication, primarily due to the large unmet need in this group of patients. Currently, belinostat does not hold any approvals in Europe.
- DigitalLook. Clinigen and Onxeo launch managed access programme for belinostat. 2017 Apr 25. https://www.digitallook.com/news/aim-bulletin/clinigen-and-onxeo-launch-managed-access-programme-for-belinostat--2638343.html. [Accessed 2017 May 02].