FDA Approves 1st Drug For Tardive Dyskinesia

African American businesswoman with natural hairIngrezza (valbenazine), the first drug to treat adults with the neurological disorder tardive dyskinesia, has been approved by the U.S. Food and Drug Administration.

The disorder is characterized by repetitive involuntary movements, usually of the jaw, lips and tongue. Affected people may stick out the tongue, smack the lips, involuntarily move the arms and legs, and have trouble breathing, the FDA said in a news release.

The disorder may be a side effect of older antipsychotic medications to treat conditions such as schizophrenia, depression or bipolar disorder. It’s not known why some users of these medications develop tardive dyskinesia, while others don’t, the agency said.

“Tardive dyskinesia can be disabling and can further stigmatize patients with mental illness,” said Dr. Mitchell Mathis, director of the FDA’s Division of Psychiatry Products. “Approving the first drug for the treatment of tardive dyskinesia is an important advance for patients suffering with this condition.”