The US Food and Drug Administration (FDA) has approved Teva Pharmaceuticals’ AUSTEDO XR extended-release tablets as a once-daily treatment option for adults with tardive dyskinesia (TD) and Huntington’s disease (HD) chorea.

The approval has been granted for AUSTEDO XR as one pill in four new tablet strengths of 30, 36, 42 and 48mg.

TD Patients may notice symptom improvement within two weeks of starting AUSTEDO XR.

Those with HD chorea can expect a significant reduction in their Total Motor Score (TMC), with clinical trials showing sustained results over three years.

AUSTEDO XR – the once-daily version of AUSTEDO – provides the most once-daily dosing options of any vesicular monoamine transporter 2 (VMAT2) inhibitor, offering enhanced flexibility for effective TD and HD chorea management.

Both are FDA-approved VMAT2 inhibitors for adults to treat TD and chorea associated with HD.

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A notable advantage of AUSTEDO XR and its twice-daily counterpart AUSTEDO is that there are no restrictions on their usage along with CYP3A4/5 inducers or inhibitors.

This is particularly beneficial for patients who require multiple medications to manage their conditions.

The safety and effectiveness of AUSTEDO XR in paediatric patients have not yet been established.

Teva Pharmaceuticals US Innovative Medicines head and senior vice-president Dell Faulkingham stated: “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.

“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.”

In April 2024, Teva Pharmaceuticals and Alvotech announced FDA approval for Selarsdi (ustekinumab-aekn) via subcutaneous injection.