On 26 October 2018, orphan designation (EU/3/18/2072) was granted by the European Commission to FGK Representative Service GmbH, Germany, for 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate (also known as ELX-02) for the treatment of cystic fibrosis.
The sponsorship was transferred to TMC Pharma (EU) Limited, Ireland, in October 2020.
|Disease / condition||
Treatment of cystic fibrosis
|Date of first decision||
|EU designation number||
Review of designation
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.