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.

Update: 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.

Key facts

Active substance
Medicine name
Disease / condition
Treatment of non-24-hour sleep-wake disorder in blind people with no light perception
Date of decision
Orphan decision 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 Limited
25 Old Broad Street
Level 21a
London EC2N 1HQ
United Kingdom
Tel. +44 (0) 207 903 5375
Fax +44 (0) 207 903 5333

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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