Teva gets FDA 'Breakthrough' status for SD-809 for the treatment of tardive dyskinesia

Israeli drugmaker Teva Pharmaceutical Industries (NYSE: TEVA) has received US Food and Drug Administration Breakthrough Therapy designation status for 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 USA.

Breakthrough 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. For SD-809, the designation request included results from Teva’s Phase II/III study, Aim to Reduce Movements in Tardive Dyskinesia (ARM-TD). In the ARM-TD study, SD-809 was compared to placebo for change in Abnormal Involuntary Movement Scale (AIMS) score from baseline to end of therapy.

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