Priority Review for Teva NDA for Tardive Dyskinesia Drug

FDA has accepted for priority review a Teva Pharmaceutical Industries NDA for SD-809 (deutetrabenazine) for treating tardive dyskinesia. The submission is based on results from two Phase 3 studies, ARM-TD (Aim to Reduce Movements in Tardive Dyskinesia) and AIM-TD (Addressing Involuntary Movements in Tardive Dyskinesia). The agency has set a user fee review target date of 8/30.

In the ARM-TD study, the primary endpoint of the change in the Abnormal Involuntary Movement Scale (AIMS) from baseline to end of therapy was met, according to Teva. “The study results show patients taking SD-809 achieved an improvement of 3.0 points on the AIMS score from baseline to end of therapy compared to 1.6 points in placebo (p = 0.0188) for a clinically meaningful effect,” it says. “Study results also demonstrated a favorable safety and tolerability profile of SD-809.” The AIM-TD study showed similar results.