FDA approval was based on data from the Kinect 3 study, which compared Ingrezza 80mg and 40mg against placebo over six weeks in patients with underlying schizophrenia, schizoaffective disorder or mood disorder.
The Kinect 3 study, which is a phase III, randomized, double-blind, placebo-controlled, parallel-group, and fixed-dose trial, has met its primary endpoint.
According to the company, the clinical studies have demonstrated that Ingrezza offered significant and rapid symptoms compared against placebo through six weeks, with continued reductions in TD observed through 48 weeks of treatment.
Ingrezza is believed to work by reducing the amount of dopamine released in a region of the brain that controls movement and motor function, enabling to regulate nerve signaling in adults with TD.
VMAT2 is a protein in the brain, which carries neurotransmitters such as dopamine for transport and release in presynaptic neurons.
Neurocrine Biosciences CEO Kevin Gorman 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.”
Neurocrine chief medical officer Dr Christopher F. O'Brien said: "The FDA's approval of Ingrezza represents the culmination of over ten years of dedicated effort from the Neurocrine research and development teams.”
Image: The FDA campus at 10903 New Hampshire Ave, Silver Spring, Maryland. Photo: courtesy of The U.S. Food and Drug Administration.