Austedo Approved for Treatment of Tardive Dyskinesia
The FDA has approved Austedo (deutetrabenazine, Teva Pharmaceutical Industries Ltd.) tablets for the treatment of tardive dyskinesia in adults. The approval was based on results from two Phase 3 randomized placebo-controlled studies assessing the efficacy and safety of Austedo in reducing the severity of abnormal involuntary movements associated with tardive dyskinesia (AIM-TD and ARM-TD).
Austedo is the second drug approved for the treatment of tardive dyskinesia this year, joining Ingrezza (valbenazine, Neurocrine) as the only two therapies approved for the condition. Austedo was previously approved for the treatment of chorea associated with Huntington’s disease in April 2017.