April 11 The U.S. Food and Drug Administration
on Tuesday approved Neurocrine Biosciences Inc's drug
to treat tardive dyskinesia, a side effect of antipsychotic
medications characterized by uncontrolled movement of the face
and body, the company said.
The drug, Ingrezza, is the first treatment to be approved for
the irreversible disorder, which occurs in 5 percent to 8
percent of patients taking antipsychotic drugs. Ingrezza is the
company's first commercial product.
The San Diego-based company did not immediately give a price
for the drug. Last year, it said it would price Ingrezza at a
net price of between $20,000 to $60,000 per year, depending on
the required dosage.
Wall Street analysts, on average, forecast annual sales for
the drug of around $700 million by 2023, according to Thomson
Ingrezza, or valbenazine, is designed to block a protein
found in the brain that helps regulate the amount of dopamine
released into nerve cells. Antipsychotic drugs are designed to
block dopamine receptors, but in some patients the signal gets
amped up and more dopamine is released in a region of the brain
that controls movement,
Around 500,000 Americans suffer from tardive dyskinesia,
Neurocrine Biosciences Chief Executive Officer Kevin Gorman said
in an interview.
He estimated that, at best, around 100,000 of them would be
treated with Ingrezza, but a more realistic level would be
(Reporting by Deena Beasley; Editing by Jonathan Oatis)