FDA approves first drug to treat tardive dyskinesia

The US Food and Drug Administration has approved Ingrezza (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD), from Neurocrine Biosciences (Nasdaq: NBIX), whose shares shot up 19.3% to $49.50 in after-hours trading on Tuesday.

Ingrezza, a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first and only FDA-approved product indicated for the treatment of adults with TD. The FDA granted this application Fast Track, Priority Review and Breakthrough Therapy designations.

"Tardive dyskinesia can be disabling and can further stigmatize patients with mental illness," said Mitchell Mathis, 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," he noted.