The U.S. Food and Drug Administration approved a first-of-its-kind drug for adults with uncontrolled face and body movements.
The FDA has approved INGREZZA (valbenazine) capsules for treatment of tardive dyskinesia, an irreversible neurological disorder that causes repetitive involuntary movements such as grimacing, lip smacking and sticking out the tongue.
“Tardive dyskinesia can be disabling and can further stigmatize patients with mental illness,” said Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “Approving the first drug for the treatment of tardive dyskinesia is an important advance for patients suffering with this condition.”
Approximately 500,000 Americans suffer from tardive dyskinesia, a side effect of taking antipsychotic medications for long periods to treat chronic conditions including depression, schizophrenia, bipolar disorder and gastrointestinal disorders. It is unclear why the neurological disorder develops, but it tends to occur more often with older classes of antipsychotics.
INGREZZA is the first commercial product of Neurocrine Biosciences, Inc. The drug is designed to block a protein in the brain that helps regulate the amount of dopamine released into nerve cells. INGREZZA may cause serious side effects including sleepiness and heart rhythm problems.
Neurocirne said the drug is expected to launch in May but following industry trend won’t yet say how much the drug will cost. Based on competitor pricing, Wall Street analysts estimate the drug will be priced between $20,00 and $60,000 a year.
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