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FDA approves Ingrezza for tardive dyskinesia
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The FDA recently approved Ingrezza capsules for treatment of tardive dyskinesia in adults.
“Tardive dyskinesia can be disabling and can further stigmatize patients with mental illness,” Mitchell Mathis, MD, of the FDA’s Center for Drug Evaluation and Research, said in a press release. “Approving the first drug for the treatment of tardive dyskinesia is an important advance for patients suffering with this condition.”
Ingrezza (valbenazine, Neurocrine Biosciences) was granted fast track, priority review and breakthrough therapy designations from the FDA.
To determine efficacy of valbenazine, researchers conducted a clinical trial among 234 individuals.
After 6 weeks, study participants who received valbenazine exhibited greater improvement in severity of abnormal involuntary movements, compared with those who received placebo.
Continued reductions in tardive dyskinesia occurred through 48 weeks of treatment.
Valbenazine was studied among more than 1,000 individuals in more than 20 clinical trials, according to a company press release.
Valbenazine may cause side effects, including sleepiness and QT prolongation, according to the FDA.
Clinicians should not prescribe valbenazine to individuals with congenital QT syndrome or abnormal heartbeat associated with a prolonged QT interval.
“Until now, one of the few options for physicians, when managing [tardive dyskinesia], was to stop, change or lower the dose of antipsychotic medication, potentially jeopardizing patients' psychiatric stability,” Christoph U. Correll, MD, of Hofstra Northwell School of Medicine, said in the release. “In clinical trials, Ingrezza significantly and rapidly improved [tardive dyskinesia] symptoms compared to placebo, reducing involuntary movements acutely and through 48 weeks of treatment without compromising underlying psychiatric care. These results, combined with convenient once-daily dosing, represent a tremendous breakthrough for patients suffering from [tardive dyskinesia].”
Valbenazine will begin distribution next week, April 17, and will be available through a select pharmacy network, according to Neurocrine Biosciences.
Promotion to health care professionals will begin May 1.