BRIEF—FDA approves Austedo XR as one pill taken once-daily

The US Food and Drug Administration (FDA) has approved Teva Pharmaceutical's Austedo XR (deutetrabenazine), as a one pill, once-daily treatment option, now with four new tablet strengths (30, 36, 42, 48 mg) indicated in adults for tardive dyskinesia (TD) and Huntington’s disease (HD) chorea.

Patients with TD taking Austedo XR can expect symptom improvement as early as two weeks while patients with HD chorea may experience a significant reduction in TMC score, with three years of the longest TD and HD chorea clinical trials and sustained results to date

“Since our launch of Austedo in 2017, we have been committed to helping people living with TD and HD chorea treat these chronic, involuntary movements,” said Dell Faulkingham, senior vice president, head of US Innovative Medicines at Teva.

“Austedo, backed by the longest efficacy and tolerability data to date, has continued to evolve - having received approval for Austedo XR, our once-daily extended-release formulation in February 2023. This latest milestone offers a streamlined treatment regimen for clinically therapeutic doses with the broadest dosing flexibility,” he added.