Teva takes another shot with Huntington’s drug in US
Teva has refiled its SD-809 drug for uncontrolled movements, or chorea, associated with Huntington’s Disease in the US, following a rejection by the US Food and Drug Administration earlier this year.
In May, the FDA rejected the drug, also known as deutetrabenazine, because it wanted Teva to examine blood levels of certain metabolites.
At the time Teva said the metabolites are not novel and are seen in subjects who take tetrabenazine, as well as deutetrabenazine, which as its name suggests has been combined with deuterium (heavy hydrogen).
It is the first deuterated drug to be reviewed by the FDA, Teva noted.
No further clinical trials were needed, so Teva has been able to re-file quickly, and the FDA has set a decision date of April 3 next year.
SD-809 was granted Orphan Drug Designation for the treatment of Huntington’s by the FDA in November 2014. The filing is based on results from two phase 3 studies, FIRST-HD and ARC-HD.
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 the neurotransmitter, dopamine, in the brain.
SD-809 is being developed for the treatment of chorea associated with Huntington’s disease, a neurodegenerative movement disorder that impacts cognition, behaviour, and movements.
The drug was developed by US drug company, Auspex Pharmaceuticals, which Teva bought last year for $3.5 billion.
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