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Teva is approved from FDA for Austedo XR for tardive dyskinesia

Teva Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for Austedo XR (deutetrabenazine) extended-release tablets to treat tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD).

The new once-daily Austedo XR is now approved in 6mg, 12mg, and 24mg extended-release tablet strengths. All three doses can be administered with or without food.

It is said to be an additional formulation of the twice-daily Austedo, which is currently marketed.

Austedo is claimed to be the only vesicular monoamine transporter 2 (VMAT2) inhibitor that received approval for treating TD and chorea associated with HD.

Teva Pharmaceuticals chief medical officer and R&D executive vice-president Eric Hughes said: “The approval of Austedo XR is a reflection of our ongoing innovation for people living with TD and HD chorea.

“For some patients living with TD and HD, treatment adherence can be a challenge that this new once-daily dosing option can help to address.”

The company stated that the once-daily Austedo XR was found to be therapeutically equivalent to the formulation that is given twice a day.

The new three-tablet strengths offer an updated regimen that may result in a reduced pill count for patients against the twice-daily formulation.

Teva intends to make Austedo XR available later this year in the US.

Teva North America Commercial executive vice-president Sven Dethlefs said: “Today’s approval marks an exciting milestone for patients with TD and HD chorea.

“Our commitment to patients suffering from these diseases is unwavering, and we will continue our mission to address the needs of patients with neurodegenerative disorders.”

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