FDA approves Ingrezza (valbenazine) capsules for the treatment of adults with tardive dyskinesia.- Neurocrine Biosciences, Inc.

Neurocrine Biosciences, Inc. announced that the FDA has approved Ingrezza (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD). Ingrezza, a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first and only FDA-approved product indicated for the treatment of adults with TD.

Clinical studies have shown that Ingrezza provides significant, rapid and meaningful improvement in TD signs and symptoms compared to placebo through six weeks, with continued reductions in TD observed through 48 weeks of treatment. Ingrezza was generally well tolerated, with somnolence as the only adverse event occurring at a rate greater than or equal to 5 percent and twice placebo. In clinical trials, no worsening in safety scale scores for depression, suicidal ideation or behaviors was observed. Ingrezza has been studied in over 1,000 individuals and more than 20 clinical trials.

Comment: Teva is developing deutetrabenazine as a potential treatment for tardive dyskinesia, a condition characterized by involuntary, repetitive movements of the extremities or face. Teva has conducted a Phase III efficacy and safety study, known as AIM-TD, of deutetrabenazine in patients with moderate-to-severe TD and has filed an application at the FDA with a PDUFA date of 30 August 2017 .