FDA OKs Neurocrine Biosciences’s neurological disorder drug

The U.S. Food and Drug Administration has approved Neurocrine Biosciences’s Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia.

FDA said that this is the first drug approved for this condition and it has granted this application Fast Track, Priority Review and Breakthrough Therapy designations.

“The FDA’s approval of Ingrezza represents the culmination of over ten years of dedicated effort from the Neurocrine research and development teams,” said Christopher F. O’Brien, MD, Neurocrine’s Chief Medical Officer.

Tardive dyskinesia is a neurological disorder characterized by repetitive involuntary movements, usually of the jaw, lips and tongue, such as grimacing, sticking out the tongue and smacking the lips. Some affected people also experience involuntary movement of the extremities or difficulty breathing.

The efficacy of Ingrezza was shown in a clinical trial of 234 participants that compared Ingrezza to placebo. After six weeks, participants who received Ingrezza had improvement in the severity of abnormal involuntary movements compared to those who received placebo, FDA explained.