EU/3/18/1989

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.

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 decision
21/03/2018
Outcome
Positive
Orphan decision 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

FGK Representative Service GmbH
Heimeranstrasse 35
80339 Munich
Germany
Tel. + 49 89 893 119 22
Email: info@fgk-rs.com

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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