FDA approves Neurocrine Biosciences’ Ingrezza for tardive dyskinesia

Neurocrine Biosciences has achieved a major milestone with the U.S. Food and Drug Administration (FDA) approving its medication, Ingrezza (valbenazine) capsules, for the treatment of adults with tardive dyskinesia. This approval marks Ingrezza as the first drug of its kind, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, specifically approved to address this neurological condition.

Groundbreaking Development in Neurological Care

Tardive dyskinesia, which affects at least 500,000 people in the US, involves uncontrollable, abnormal movements of the face, trunk, and extremities. It is often a consequence of long-term use of antipsychotic medications and other drugs that affect dopamine signaling in the brain. Ingrezza works by moderating the amount of dopamine released in regions of the brain associated with motor function, thus alleviating symptoms of the disorder.

Clinical Trial Success

The FDA’s approval was significantly influenced by the results from the Kinect 3 study—a phase 3, double-blind, randomized, placebo-controlled, parallel-group trial. This study evaluated the efficacy of 800mg and 400mg doses of Ingrezza over a six-week period in patients with conditions such as schizophrenia, schizoaffective disorder, or mood disorder. Ingrezza demonstrated a rapid and significant improvement in symptoms compared to placebo, with these improvements continuing throughout a 48-week treatment period.

Expert and Executive Insights

Kevin C. Gorman, CEO of Neurocrine Biosciences, expressed his enthusiasm about the approval: “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.”

Christoph U. Correll, MD, Professor of Psychiatry and Molecular Medicine at Hofstra Northwell School of Medicine, also highlighted the clinical impact of Ingrezza, stating, “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.”

Expanding Access and Enhancing Treatment

With the approval, Neurocrine Biosciences is committed to ensuring that those impacted by tardive dyskinesia have accessible, effective treatment options. This commitment is part of Neurocrine’s broader mission to develop treatments for underserved patient populations and complex medical conditions.

The FDA approval of Ingrezza is a landmark event in the treatment of neurological disorders, particularly tardive dyskinesia. It not only offers hope to thousands of affected individuals but also represents a significant advancement in how these types of conditions can be managed more effectively without compromising the treatment of underlying psychiatric disorders.