FDA Approves Ingrezza for Tardive Dyskinesia

FDA has approved a Neurocrine Biosciences NDA for Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia, a neurological disorder characterized by repetitive involuntary movements of the jaw, lips and tongue. The disorder is a serious side effect associated with patients who have been treated with antipsychotic medications, especially the older medications, for long periods to treat chronic conditions, such as schizophrenia and bipolar disorder.

Approval was based on data from a clinical trial in 234 participants that compared Ingrezza to placebo. “After six weeks, participants who received Ingrezza had improvement in the severity of abnormal involuntary movements compared to those who received placebo,” an agency release says. A labeled warning is being required about the drug’s potential side effect including sleepiness and heart rhythm problems (QT prolongation).