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Pharmaceuticals / Submissions and Approvals

FDA Approves Ingrezza as First Treatment for Tardive Dyskinesia

April 14, 2017

Neurocrine Biosciences’ Ingrezza (valbenazine) capsules received the first FDA approval for the treatment of adults with tardive dyskinesia, a movement disorder affecting the mouth, tongue and face. Ingrezza is a selective vesicular monoamine transporter 2 inhibitor.

According to the company, over 20 clinical trials enrolling more than 1,000 patients demonstrated significant improvement in signs and symptoms with Ingrezza compared to placebo through six weeks, with continued reductions observed over 48 weeks of treatment.

The FDA had scheduled an advisory committee meeting for Ingrezza in January, but it canceled that meeting after further review.

Neurocrine says Ingrezza will be available through a select pharmacy network as early as next week, with promotion to healthcare professionals beginning May 1.

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