EU/3/09/670: Orphan designation for the treatment of acromegaly
Table of contents
On 8 October 2009, orphan designation (EU/3/09/670) was granted by the European Commission to Novartis Europharm Limited, United Kingdom, for pasireotide for the treatment of acromegaly.
Pasireotide in treatment of acromegaly has been authorised in the EU as Signifor since 19 November 2014.
The sponsorship was transferred to Novartis Europharm Limited, Ireland, in May 2018.
The sponsorship was transferred to Recordati Rare Diseases, France in May 2020.
Treatment of acromegaly
|Orphan designation status||
|EU designation number||
|Date of designation||
Recordati Rare Diseases
Review of designation
During its meeting of 7 to 9 October 2014, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/09/670 for Signifor (pasireotide) as an orphan medicinal product for the treatment of acromegaly. The COMP assessed whether, at the time of addition of a new indication to the 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. As other methods of treatment are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with acromegaly. 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.
Documents related to this orphan designation evaluation
Recommendation for maintenance of orphan designation at the time of marketing authorisation: Signifor (pasireotide) for the treatment of acromegaly (PDF/79.15 KB)
First published: 21/01/2015
Last updated: 21/01/2015
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: