Neurocrine Biosciences has beaten rival Teva Pharmaceuticals in the race to win the FDA's first approval of a drug to treat tardive dyskinesia (TD). Yesterday afternoon, the agency confirmed approving Neurocrine’s oral vesicular monoamine transporter 2 (VMAT2) inhibitor Ingrezza™ (valbenazine) for the involuntary movement disorder. Teva Pharmaceuticals’ VMAT2 inhibitor Austedo™ (deutetrabenazine) is currently under FDA review for the TD indication, with a PDUFA date of August 30th. Within the last 10 days, the agency approved Austedo for treating chorea associated with Huntington’s disease.
FDA approval of Ingrezza for TD was based on data from the placebo-controlled Phase III study Kinect 3 in 234 patients with underlying schizophrenia, schizoaffective disorder, or mood disorders. The results showed that Ingrezza treatment significantly improved the severity of involuntary movements after 6 weeks. A total of 40% of participants given Ingrezza achieved at least a 50% reduction in the Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score, compared with 8.7% of placebo patients. Neurocrine says clinical trials have demonstrated continued reductions in TD symptoms through to 48 weeks.
“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,” said Kevin C. Gorman, Ph.D., Neurocrine Biosciences CEO.
Ingrezza can be taken in combination with antipsychotics or antidepressants. “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,” said Christoph U. Correll, M.D., professor, psychiatry and molecular medicine, at Hofstra Northwell School of Medicine. “These results, combined with convenient once-daily dosing, represent a tremendous breakthrough for patients suffering from TD.”
Neurocrine and Teva are both also developing their respective VMAT2 inhibitors for treating Tourette's syndrome. In January, Neurocrine reported that its Phase II T-Forward Ingrezza study in adult patients failed to meet its primary endpoint of improvements in the Yale Global Tic Severity Scale (YGTSS), although treatment did significantly improve overall Tourette's symptoms assessed by the Clinical Global Impression of Change score. The firm said it would now wait for results from the Phase II T-Force GREEN study in pediatric patients before speaking with the FDA about a potential way forward for Phase III.
In February, Neurocrine confirmed a potentially $145 million deal with Portuguese firm BIAL to acquire North American rights to the latter's EU-approved Parkinson’s disease drug Ongentys® (opicapone).