close

Products

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:

  • peptide. As an unacylated ghrelin analog, AZP-531 is expected to improve hyperphagia by inhibiting the effects of increased acylated ghrelin blood levels in these patients. It is also expected to decrease weight and improve glucose control, a key additional benefit as 25% of adult Prader-Willi patients have type 2 diabetes.

Company: Alize Pharma (France)

Disease: Prader-Willi syndrome

Latest news:

  • • On October 16, 2017, the European Commission has granted orphan drug designation for livoletide (AZP-531 synthetic cyclic 8 amino acid analog of human unacylated ghrelin) for treatment of Prader-Willi syndrome.
  • • On October 12, 2017, the FDA has granted orphan drug designation for livoletide (AZP-531 synthetic cyclic 8 amino acid analog of human unacylated ghrelin) for treatment of Prader-Willi syndrome.
   

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:

Is general: Yes