FDA approves Austedo XR for tardive dyskinesia, Huntington’s disease chorea

Teva Pharmaceuticals announced FDA approval of Austedo XR, a once-daily, extended-release formulation for adults with tardive dyskinesia and chorea associated with Huntington’s disease.

According to a release from Teva, Austedo/Austedo XR (deutetrabenazine) is the first and only vesicular monoamine transporter 2 inhibitor approved by the FDA. The new, once-daily formulation is now approved in 6, 12 and 24 mg tablets, which can be taken with or without food, and can reduce the pill count for individuals on the currently available twice-daily formulation.

“The approval of Austedo XR is a reflection of our ongoing innovation for people living with TD and HD chorea,” Eric Hughes, MD, PhD, executive vice president of research and development and chief medical officer at Teva, said in the release. “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.”

Austedo XR is expected to be available in the United States later this year, the company stated.

“Today’s approval marks an exciting milestone for patients with TD and HD chorea,” Sven Dethlefs, PhD, Teva’s executive vice president of North America commercial, said in the release. “Our commitment to patients suffering with these diseases is unwavering and we will continue our mission to address the needs of patients with neurodegenerative disorders.”