FDA Accepts Teva’s NDA for CNS Orphan Drug

Teva Pharmaceutical Industries Ltd.’s new drug application (NDA) for SD-809 (deutetrabenazine) has been accepted by the US Food and Drug Administration (FDA) for treating chorea associated with Huntington disease (HD), a rare and fatal neurodegenerative disorder caused by the progressive breakdown of nerve cells in the brain.

SD-809 was granted orphan drug designation for the treatment of HD by the FDA in November 2014 and became part of Teva's portfolio with the acquisition of Auspex Pharmaceuticals in May 2015. The FDA designates orphan status to drugs and biologics that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the US.

SD-809 is an investigational, oral, small molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, that is designed to regulate the levels of a specific neurotransmitter, dopamine, in the brain. SD-809 is being developed for the treatment of chorea associated with Huntington disease, a neurodegenerative movement disorder that impacts cognition, behavior, and movements.

Source: Teva Pharmaceutical Industries

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