Date: 2016-04-14
Type of information: Granting of the orphan status in the US
Product name: Debio 1143 - (5S,8S,10aR)-N-benzhydryl-5-((S)-2-(methylamino)propanamido)-3-(3-methylbutanoyl)-6-oxodecahydropyrrolo[1,2-a][1,5]diazocine-8-carboxamide
Compound: (5S,8S,10aR)-N-benzhydryl-5-((S)-2-(methylamino)propanamido)-3-(3-methylbutanoyl)-6-oxodecahydropyrrolo[1,2-a][1,5]diazocine-8-carboxamide
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism: Debio 1143 is an oral, small molecule inhibitor of IAPs (Inhibitor of Apoptosis Proteins) with a dual pro-apoptotic and immunomodulatory mode of action developed as a potent chemo/radio-sensitizer in oncology.
Company: Asphalion (Spain) Debiopharm (Switzerland)
Disease: ovarian cancer
Latest news: * On April 14, 2016, the FDA has granted orphan drug designation for (5S,8S, 10aR)-N-benzhydryl-5-((S)-2-(methylamino)propanamido)-3-(3-methylbutanoyl)-6-oxodecahydropyrrolo[1,2-a][1,5] diazocine-8-carboxyamide for treatment of ovarian cancer. * On October 6-8, 2015, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for (5S,8S,10aR)-N-benzhydryl-5-((S)-2-(methylamino)propanamido)-3-(3-methylbutanoyl)-6-oxodecahydropyrrolo[1,2-a][1,5]diazocine-8-carboxamide for treatment of ovarian cancer.
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: 2016-04-14
Orphan status UE: 2015-11-11
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
