Date: 2017-04-03
Type of information: Granting of a Market Authorisation in the US
Product name: Austedo™ (SD-809 - deutetrabenazine)
Compound: deutetrabenazine
Therapeutic area: Rare diseases - Neurodegenerative 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 was granted Orphan Drug Designation for the treatment of Huntington disease by the FDA in November 2014. The compound 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: chorea associated with Huntington disease
Latest news:
- • On April 3, 2017, Teva Pharmaceutical announced that the FDA has approved Austedo™ (deutetrabenazine) tablets for the treatment of chorea associated with Huntington's disease. Austedo™ is the first deuterated product approved by the FDA and only the second product approved in Huntington's disease.
- The FDA approval was based on results from a Phase III randomized, placebo-controlled study to assess the safety and efficacy of Huntington's disease in reducing chorea in patients with HD (First-HD).
- The efficacy of Austedo™ as a treatment for chorea associated with Huntington's disease was established in a randomized, double-blind, placebo-controlled, multi-center trial conducted in 90 ambulatory patients with manifest chorea associated with Huntington's disease. Total Maximal Chorea Scores for patients receiving Austedo™ improved by approximately 4.4 units from baseline to the maintenance period (average of Week 9 and Week 12), compared to approximately 1.9 units in the placebo group. The treatment effect of -2.5 units was statistically significant (p<0.0001). The Maintenance Endpoint is the mean of the Total Maximal Chorea Scores for the Week 9 and Week 12 visits. At the Week 13 follow-up visit (1 week after discontinuation of the study medication), the Total Maximal Chorea Scores of patients who had received Austedo™ returned to baseline.
- • On May 31, 2016, Teva Pharmaceutical announced that it has received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for SD-809 (deutetrabenazine) tablets for the treatment of chorea associated Huntington disease. This is the first deuterated product to be reviewed by the FDA . The FDA has asked Teva to examine blood levels of certain metabolites. These metabolites are not novel, and are the same seen in subjects who take tetrabenazine or deutetrabenazine. No new clinical trials have been requested.
- • On August 12, 2015, Teva Pharmaceutical announced that the New Drug Application (NDA) for SD-809 (deutetrabenazine) has been accepted by the FDA for the treatment of chorea associated with Huntington disease.
- The NDA filing is based on positive results from two Phase-III studies, FIRST-HD and ARC-HD. In the placebo-controlled, randomized FIRST-HD study, SD-809 reduced chorea in patients with Huntington disease. Positive top-line data from the Phase-III, open-label ARC-HD study demonstrated that patients were able to safely convert from tetrabenazine, currently the only approved Huntington disease treatment, to SD-809 overnight with continued control of chorea.
- • On November 5, 2014, the FDA has granted orphan drug designation for d6-tetrabenazine, deutetrabenazine for the treatment of Huntington's disease . Auspex is currently evaluating the efficacy and safety of SD-809 for treating chorea associated with this disorder in a Phase 3 registration clinical trial and is on track to announce topline data from this study in December 2014.
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: 2017-04-03
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA: 2014-11-05
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
