FDA Grants Breakthrough Therapy Status to Teva’s Deutetrabenazine
Teva Pharmaceutical Industries Ltd. reports that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation status to SD-809 (deutetrabenazine) for the treatment of patients with moderate-to-severe tardive dyskinesia, a hyperkinetic movement disorder affecting about 500,000 people in the United States.
Breakthrough therapy designation is granted to a drug that is intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint over available therapy or placebo where there is no available therapy.
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. SD-809 is being developed for the treatment of chorea associated with Huntington's disease, a neurodegenerative movement disorder that impacts cognition, behavior, and movements. Teva is investigating the broad potential of SD-809 for treating additional movements disorders such as tardive dyskinesia and tics associated with Tourette syndrome.
Source: Teva Pharmaceutical Industries