EU/3/17/1855: Orphan designation for the treatment of Lennox-Gastaut syndrome



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.

Key facts

Active substance
Intended use
Treatment of Lennox-Gastaut syndrome
Orphan designation status
EU designation number
Date of designation

Jazz Pharmaceuticals Ireland Ltd
Fifth Floor, Waterloo Exchange
Waterloo Road
Dublin 4
Ireland D04 E5W7
Tel: +35316347800

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 PDF icon orphan medicine assessment report .

Update history

April 2019The sponsorship was transferred to GW Pharma (International) B.V., the Netherlands.
June 2023The sponsorship was transferred from GW Pharma (International) B.V., The Netherlands to Jazz Pharmaceuticals Ireland Limited, Ireland.

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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