Teva Pharmaceutical Industries is seeking approval from the US Food and Drug Administration (FDA) for its SD-809 (deutetrabenazine) for treatment in Huntington’s disease (HD).
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FDA has accepted the firm’s new drug application (NDA) for SD-809 to treat chorea associated with HD, a rare and fatal neurodegenerative disorder caused by the progressive breakdown of nerve cells in the brain.
The SD-809 is an investigational, oral and small molecule inhibitor of vesicular monoamine 2 transporter (VMAT2), which is designed to regulate the levels of a specific neurotransmitter, dopamine, in the brain.
Teva global R&D president and chief scientific officer Dr Michael Hayden said: "The opportunity to bring a new treatment option to those battling the devastating illness of Huntington’s disease is an important first step and an indication of our profound commitment to improving the lives of patients with this and other debilitating movement disorders."
The NDA was submitted based on positive results from two Phase-III studies, FIRST-HD and ARC-HD.
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By GlobalDataThe SD-809 reduced chorea in patients with HD in the placebo-controlled and randomised FIRST-HD study.
ARC-HD study’s positive top-line data showed that patients were able to safely convert from tetrabenazine to SD-809 overnight with continued control of chorea.
The FDA granted orphan drug status for SD-809 to treat HD in November 2014, while it was included in the firm’s CNS portfolio with the acquisition of Auspex Pharmaceuticals in May this year.
Image: Coronal section from MR brain scan of a patient with HD. Photo: courtesy of Frank Gaillard.
