New Therapy for Chorea Associated with Huntington’s Disease Wins FDA Approval

Tuesday, April 04, 2017 | FDA Approval/Clearance , Movement Disorders , Neuromuscular & Immune Disorders , Phase 3/4 Trials


The FDA approved Austedo (deutetrabenazine, Teva Pharmaceuticals) tablets for the treatment of chorea associated with Huntington’s disease (HD), making it just the second product approved for the disease. The approval was based on results from a phase 3 randomized, placebo-controlled study to assess the safety and efficacy of Austedo in reducing chorea in patients with HD (First-HD). In 90 ambulatory patients with manifest chorea associated with Huntington’s disease. Total Maximal Chorea Scores for patients receiving Austedo improved by approximately 4.4 units from baseline to the maintenance period (average of Week 9 and Week 12), compared to approximately 1.9 units in the placebo group. The treatment effect of -2.5 units was statistically significant. The Maintenance Endpoint is the mean of the Total Maximal Chorea Scores for the Week 9 and Week 12 visits. One week after discontinuation of the study medication), the Total Maximal Chorea Scores of patients who had received Austedo returned to baseline.

            Previously referred to by the developmental name SD-809, Austedo is the first deuterated product to earn FDA approval.

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