FDA approves Austedo (deutetrabenazine) for the treatment of tardive dyskinesia in adults.-Teva.
The FDA has approved Austedo (deutetrabenazine), from Teva Pharmaceutical Industries, for the treatment of tardive dyskinesia (TD) in adults. Deutetrabenazine, marketed as Austedo, was approved in April 2017 for the treatment of chorea associated with Huntington�s disease. The approval comes less than 5 months after Ingrezza (valbenazine) from Neurocrine Biosciences became the first drug approved as a treatment for TD.
Deutetrabenazine, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, received Breakthrough Therapy designation for the treatment of TD from the FDA in November 2015. The approval was based on results from two Phase III studies, AIM-TD and ARM-TD.
Comment: Tardive dyskinesia is a debilitating movement disorder characterised by repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities, affecting around 500,000 people in the US.
Comment: Ingrezza is a fixed-dose product, with patients receiving either 40 mg or 80 mg. Ingrezza is dosed once-daily, compared with twice-daily Austedo, which makes Ingrezza better placed to improve adherence.
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