EU/3/10/841: Orphan designation for the treatment of non-24-hour sleep-wake disorders in blind people with no light perception



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.

Key facts

Active substance
Medicine name
Intended use
Treatment of non-24-hour sleep-wake disorders in blind people with no light perception
Orphan designation status
EU designation number
Date of designation

Vanda Pharmaceuticals Netherlands B.V.
Basisweg 10
1043 AP Amsterdam

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.

Update history

June 2023The sponsor’s address was updated in June 2023.

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Hetlioz (tasimelteon) for the treatment of non-24-hour sleep-wake disorder (PDF/77.31 KB)


    First published: 27/07/2015
    Last updated: 27/07/2015

  • 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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