On 26 April 2013 orphan designation (EU/3/13/1123) was granted by the European Commission to Boehringer Ingelheim International GmbH, Germany, for nintedanib for the treatment of idiopathic pulmonary fibrosis.
Nintedanib has been authorised in the EU as Ofev since 15 January 2015.
|Disease / condition||
Treatment of idiopathic pulmonary fibrosis
|Date of first decision||
|EU designation number||
Review of designation
During its meeting of 9 to 11 December 2014, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/13/1123 for Ofev (nintedanib) as an orphan medicinal product for the treatment of idiopathic pulmonary fibrosis. 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. 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 idiopathic pulmonary fibrosis. The COMP recommended that the orphan designation of the medicine be maintained1.
1The 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
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.