Date: 2017-10-16
Type of information: Granting of the orphan status in the EU
Product name: livoletide (AZP-531)
Compound: synthetic cyclic 8 amino acid analogue of human unacylated ghrelin
Therapeutic area: Rare diseases - Genetic diseases
Action mechanism:
Company: Alize Pharma (France)
Disease: Prader-Willi syndrome
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: 2017-10-12
Orphan status UE: 2017-10-16
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news: