EU/3/18/1989
Table of contents
About
On 21 March 2018, orphan designation (EU/3/18/1989) was granted by the European Commission to FGK Representative Service GmbH, Germany, for (2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidine-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridine-2-yl) -4-fluoropyrrolidine-2-carboxamide (also known as ACH-0144471) for the treatment of C3 glomerulopathy.
The sponsorship was transferred to Alexion Europe S.A.S. France, in June 2020.
Key facts
Active substance |
(2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidine-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridine-2-yl)-4-fluoropyrrolidine-2-carboxamide
|
Disease / condition |
Treatment of C3 glomerulopathy
|
Date of first decision |
21/03/2018
|
Outcome |
Positive
|
EU designation number |
EU/3/18/1989
|
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
Sponsor's contact details
Alexion Europe S.A.S.
103-105 Rue Anatole France
92300 Levallois Perret
France
E-mail: MedInfo@alexion.com
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.