Date: 2016-02-17
Type of information: Granting of the orphan status in the EU
Product name: EYS-606 - DNA plasmid encoding a recombinant fusion protein consisting of the extracellular domain of human TNF? p55 receptor linked to the human IgG1 Fc domain
Compound: DNA plasmid encoding a recombinant fusion protein consisting of the extracellular domain of human TNF? p55 receptor linked to the human IgG1 Fc domain
Therapeutic area: Rare diseases - Ophtalmological diseases
Action mechanism: gene therapy. EYS-606 is a soluble TNFa receptor plasmid.
Company: Eyevensys (France)
Disease: non-infectious uveitis
Latest news: * On January 27, 2016, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for DNA plasmid encoding a recombinant fusion protein consisting of the extracellular domain of human TNF? p55 receptor linked to the human IgG1 Fc domain for treatment of non-infectious uveitis.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE: 2016-02-17
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
