Investigational Agent for Huntington's Disease to Be Reviewed by FDA
Teva Pharmaceutical announced that the New Drug Application (NDA) for SD-809 (deutetrabenazine) has been accepted by the Food and Drug Administration (FDA) for the treatment of chorea associated with Huntington's disease (HD), rare and fatal neurodegenerative disorder caused by the progressive breakdown of nerve cells in the brain that affects about five to seven people per 100,000 in western countries.
The NDA filing is based on positive results from two Phase 3 studies. FIRST-HD, a placebo-controlled, randomized study, demonstrated that SD-809 reduced chorea in patients with HD. ARC-HD, an open-label study, demonstrated that patients were able to safely convert from tetrabenazine, currently the only approved drug for Huntington's chorea, to SD-809 overnight with continued control of chorea.
Deutetrabenazine is an oral, small molecule inhibitor of vesicular monoamine 2 transporter (VMAT2) that is designed to regulate the levels of dopamine in the brain.
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