On 23 February 2011, orphan designation (EU/3/10/841) was granted by the European Commission to Vanda Pharmaceuticals Limited, United Kingdom, for tasimelteon for the treatment of non-24-hour sleep-wake disorder in blind people with no light perception.
Tasimelteon (Hetlioz) has been authorised in the EU since 3 July 2015 for treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.
The sponsorship was transferred to Vanda Pharmaceuticals Germany GmbH, Germany, in January 2019 and subsequently to Vanda Pharmaceuticals Netherlands B.V., Netherlands, in September 2020.
|Disease / condition||
Treatment of non-24-hour sleep-wake disorders in blind people with no light perception
|Date of first decision||
|EU designation number||
Review of designation
During its meeting of 12 to 13 May 2015, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/10/841 for Hetlioz (tasimelteon) as an orphan medicinal product for the for the treatment of non-24-hour sleep-wake disorder. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other methods of treatment. The COMP recommended that the orphan designation of the medicine be maintained*.
*The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with a comparable therapeutic indication cannot be placed on the market.
Sponsor's contact details
Vanda Pharmaceuticals Netherlands B.V.
Prins Bernhardplein 200
1097 JB Amsterdam
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.