Date: 2014-01-08
Type of information: Granting of the orphan status in the EU
Product name: GS010- adeno-associated viral vector containing the human NADH dehydrogenase 4 gene
Compound: adeno-associated viral vector containing the human NADH dehydrogenase 4 gene
Therapeutic area: Rare diseases - Genetic diseases - Ophtalmological diseases
Action mechanism: gene therapy
Company: Gensight-Biologics (France)
Disease: Leber's hereditary optic neuropathy (LHON)
Latest news:
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: 2013-11-20
Orphan status UE: 2011-05-19 and 2013-10-03
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news: