Date: 2017-02-28
Type of information: Acceptation for review of a NDA
Product name: SD-809 - deutetrabenazine
Compound: deutetrabenazine
Therapeutic area: Neurological diseases - CNS 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.
- SD-809 is being developed for the treatment of chorea associated with Huntington's disease and Teva is also investigating the potential of the drug for treating additional movements disorders such as tardive dyskinesia and tics associated with Tourette syndrome. Last January, the FDA has granted orphan drug designation for deutetrabenazine for the treatment of Tourette syndrome in the pediatric population. The agency has also accepted Teva's New Drug Application (NDA) for SD-809 for the treatment of chorea associated with Huntington disease.
Company: Teva Pharmaceutical Industries (Israel)
Disease: tardive dyskinesia
Latest news:
- • On February 28, 2017, Teva Pharmaceutical Industries announced the FDA has accepted the New Drug Application (NDA) and granted Priority Review for SD-809 (deutetrabenazine) for the treatment of tardive dyskinesia. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 30, 2017 .
The NDA for SD-809 is based on results from two Phase III studies, ARM-TD (Aim to Reduce Movements in Tardive Dyskinesia) and AIM-TD (Addressing Involuntary Movements in Tardive Dyskinesia).
- • On November 9, 2015, Teva Pharmaceutical Industries announced that the FDA has granted Breakthrough Therapy Designation status to SD-809 (deutetrabenazine) for the treatment of patients with moderate to severe tardive dyskinesia, a hyperkinetic movement disorder affecting about 500,000 people in the United States . For SD-809, the designation request included results from Teva's Phase II/III study, Aim to Reduce Movements in Tardive Dyskinesia (ARM-TD). In the ARM-TD study, SD-809 was compared to placebo for change in Abnormal Involuntary Movement Scale (AIMS) score from baseline to end of therapy.
Patents:
Submission of marketing authorization application USA :
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Other news:
Is general: Yes
