Generics
US FDA Accepts Teva's Resubmitted New Drug Application for SD-809 for Treatment of Chorea Associated with Huntington Disease
21 October 2016 - - The US Food and Drug Administration has accepted Israeli pharmaceutical company Teva Pharmaceutical Industries Ltd.'s (NYSE: TEVA) (TASE: TEVA) resubmission of the New Drug Application for SD-809 (deutetrabenazine) for the treatment of chorea associated with Huntington disease. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of 3 April 2017, the company said.

SD-809 was granted Orphan Drug Designation for the treatment of HD by the FDA in November 2014.

The NDA filing is based on results from two Phase-III studies, FIRST-HD and ARC-HD. The resubmission of the NDA follows the receipt of a Complete Response Letter from the FDA in May 2016.

SD-809 (deutetrabenazine) 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.

It is being developed for the treatment of chorea associated with Huntington disease, a neurodegenerative movement disorder that impacts cognition, behaviour, and movements.

Huntington disease is a fatal neurodegenerative disease characterised by uncoordinated and uncontrollable movements, cognitive deterioration and behavioral and/or psychological problems.

Onset of HD symptoms typically occurs in middle age, but the disease also manifests in children and the elderly. HD is the most common genetic cause of abnormal involuntary writhing movements called chorea.

Headquartered in Israel, Teva is the world's largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area.

In specialty medicines, Teva has a position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products.

Teva's net revenues in 2015 amounted to USD 19.7bn.
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