EU/3/17/1855: Orphan designation for the treatment of Lennox-Gastaut syndrome
Table of contents
On 20 March 2017, orphan designation (EU/3/17/1855) was granted by the European Commission to GW Research Ltd, United Kingdom, for cannabidiol for the treatment of Lennox-Gastaut syndrome.
The sponsorship was transferred to GW Pharma (International) B.V., the Netherlands, in April 2019.
Cannabidiol for treatment of Dravet syndrome and treatment of Lennox-Gastaut has been authorised in the EU as Epidyolex since 19 September 2019.
Treatment of Lennox-Gastaut syndrome
|Orphan designation status||
|EU designation number||
|Date of designation||
GW Pharma (International) B.V.
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Epidyolex at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.
More information is available in the orphan medicine assessment report .
Documents related to this orphan designation evaluation
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: