SD 809 (deutetrabenazine) filed with the FDA for Huntington disease- Teva Pharmaceutical
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 (HD).
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 HD. 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 HD treatment, to SD 809 overnight with continued control of chorea.
Comment: SD 809 was granted Orphan Drug Designation for the treatment of HD by the FDA in November 2014 and became part of Teva�s CNS portfolio with the acquisition of Auspex Pharmaceuticals in May 2015.
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