The US Food and Drug Administration (FDA) has approved valbenazine for the treatment of tardive dyskinesia (TD) in adults, making it the first drug approved for the movement disorder.
The approval for valbenazine capsules (Ingrezza) was granted to Neurocrine Biosciences. The FDA previously granted Fast Track, Priority Review, and Breakthrough Therapy designations to the application.
“Tardive dyskinesia can be disabling and can further stigmatize patients with mental illness,” said Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Approving the first drug for the treatment of tardive dyskinesia is an important advance for patients suffering with this condition.”
Valbenazine is a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor. Its efficacy was shown in a 6-week clinical trial with 234 participants. Patients taking the drug saw improvement in the severity of abnormal involuntary movements, compared to the placebo group, the FDA said in a statement. Continued reductions were seen for 48 weeks of treatment, according to Neurocrine.
The company said in its statement that valbenazine has been studied in more than 1000 people through more than 20 clinical trials.
According to Neurocrine, TD is estimated to affect at least 500,000 people in the US.
“The often debilitating effects of tardive dyskinesia have left people feeling isolated and forgotten” said Kevin C. Gorman, chief executive officer of Neurocrine Biosciences. “The approval of Ingrezza represents a turning point for these patients and their care partners, offering a meaningful treatment where before there was little hope.”
Psych Congress co-chair Rakesh Jain, MD, MS, recently spoke about the promise of valbenazine and deutetrabenazine, another treatment under review by the FDA as a treatment for TD.
“I’m just amazed by these 2 drugs,” he said at Elevate by Psych Congress. “These are major innovations in psychiatry.”
“In 2017, our relationship with TD changes forever. The hopelessness, the helplessness, the shame, the embarrassment goes away, I hope,” Dr. Jain said.
Adverse effects of valbenazine include sleepiness and heart rhythm problems (QT prolongation), and the FDA said it should not be used in patients with congenital long QT syndrome or abnormal heartbeats associated with a prolonged QT interval.
Distribution of the drug will begin next week, Neurocrine officials said.
Neurocrine announces FDA approval of Ingrezza TM (valbenazine) capsules as the first and only approved treatment for adults with tardive dyskinesia (TD) [press release]. San Diego, CA: Neurocrine Biosciences; April 11, 2017.