EU/3/17/1882: Orphan designation for the treatment of growth hormone deficiency
Table of contents
On 20 June 2017, orphan designation (EU/3/17/1882) was granted by the European Commission to Richardson Associates Regulatory Affairs Ltd., United Kingdom, for ibutamoren mesilate (also known as MK-0677) for the treatment of growth hormone deficiency.
The sponsorship was transferred to Richardson Associates Regulatory Affairs Ltd, Ireland, in December 2018 and to Agos Healthcare Limited, Ireland, in December 2020.
The sponsor's address was updated in September 2021.
Treatment of growth hormone deficiency
|Orphan designation status||
|EU designation number||
|Date of designation||
Agos Healthcare Limited
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
Documents related to this orphan designation evaluation
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: