Date: 2015-01-13
Type of information: Granting of the orphan status in the US
Product name: SD-809 - deutetrabenazine
Compound: deutetrabenazine
Therapeutic area: Genetic diseases - Neurological diseases - Rare diseases
Action mechanism:
- protein inhibitor/VMAT2 inhibitor. SD-809 (deutetrabenazine) is a small molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, that is designed to regulate the levels of dopamine in the brain. SD-809 is being developed for the treatment of chorea associated with Huntington’s disease. SD-809 (deutetrabenazine) is Auspex Pharmaceuticals's lead investigational product.
- SD-809 became part of Teva’s central nervous system (CNS) product portfolio with the acquisition of Auspex Pharmaceuticals in May 2015.
Company: Auspex Pharmaceuticals (USA - CA) now Teva Pharmaceutical Industries (Israel)
Disease: Tourette syndrome in the pediatric population
Latest news:
- • On January 13, 2015, the FDA has granted orphan drug designation for deutetrabenazine for the treatment of Tourette syndrome in the pediatric population. Auspex is currently evaluating the preliminary efficacy, pharmacokinetic and safety profile of SD-809 in a Phase 1b clinical trial for the treatment of tics associated with Tourette syndrome. Topline data from this trial are expected by mid-2015. In November 2014, SD-809 was granted orphan drug designation by the FDA for the treatment of Huntington's disease.
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: 2015-01-13
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
