The US Food and Drug Administration (FDA) has approved for Ingrezza (valbenazine) capsules developed by Neurocrine Biosciences for the treatment of tardive dyskinesia patients.
A selective vesicular monoamine transporter 2 (VMAT2) inhibitor, Ingrezza has become the first drug to be approved by the regulator to treat adults suffering from tardive dyskinesia.
VMAT2 is a protein found in the brain, which is responsible for storing neurotransmitters including dopamine in packages for transport and release in presynaptic neurons.
The Chief Executive Officer of Neurocrine Biosciences, Kevin C. Gorman on Ingrezza approval from FDA, said: “The often debilitating effects of tardive dyskinesia have left people feeling isolated and forgotten. 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.
“For the past 20 years, Neurocrine has been devoted to developing treatments for difficult to manage conditions in underserved patient populations. We are committed to ensuring that those impacted by the disruptive effects of tardive dyskinesia have access to Ingrezza.”
Ingrezza approval from the FDA was driven by the Kinect 3 study data, which compared 800mg and 400mg of its strengths against placebo for a six-week period in patients having underlying conditions like schizophrenia, schizoaffective disorder or mood disorder.
The phase 3 study was a double-blind, randomized, placebo-controlled, parallel-group, and fixed-dose trial that met its primary endpoint.
Ingrezza’s clinical trials had shown that the tardive dyskinesia drug provided significant and rapid improvement in symptoms in comparison with placebo over six weeks, with continued reductions in the disease noted along during the 48-week treatment.
Christoph U. Correll, MD, Professor, Psychiatry and Molecular Medicine, Hofstra Northwell School of Medicine said: “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.
“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.”
According to Neurocrine Biosciences, Ingrezza helps in tardive dyskinesia treatment by decreasing the dopamine amount released in a region of the brain that controls body movement and motor function, allowing to moderate nerve signaling in adult patients.
Estimated to affect at least 500,000 people in the US, tardive dyskinesia is typical of unmanageable, unusual and repetitive movements of the trunk, extremities and/or face.
Tardive dyskinesia is caused by therapies that inhibit dopamine receptors in the brain, such as antipsychotics and other drugs, which are widely prescribed to treat mental illnesses like schizophrenia, depression and bipolar disorder.
In Tardive dyskinesia patients, these therapies are believed to result in improper dopamine signaling in a region of the brain that is responsible for controlling movement.