Neurocrine Biosciences Inc’s Ingrezza, capsules for the treatment of adults with tardive dyskinesia (TD) has been approved by FDA. The drug is the first treatment to be approved for this irreversible disorder, which occurs in 5 percent to 8 percent of patients taking antipsychotic drugs.
“Until now, one of the few options for physicians when managing TD was to stop, change, or lower the dose of antipsychotic medication, potentially jeopardizing patients’ psychiatric stability,” Christoph U Correll, MD, from Hofstra Northwell School of Medicine in Hempstead, New York, said in a release from the company.
Ingrezza (valbenazine) is thought to work by reducing the amount of dopamine released in a region of the brain that controls movement and motor function, helping to regulate nerve signaling in adults with TD.
The drug, is the first treatment to be approved for the irreversible disorder, which occurs in 5 percent to 8 percent of patients taking antipsychotic drugs and it also Neurocrine’s first commercial product.
According to Neurocrine Biosciences Chief Executive Officer Kevin Gorman around 500,000 Americans suffer from tardive dyskinesia and he estimated that potetentially around 100,000 of them would be treated with Ingrezza, but a more realistic level would be around 50,000.
Neurocrine said the drug is expected to launch in May with a competitive price.
Wall Street analysts, on average, forecast annual sales for the drug of around $700 million by 2023.
Also Teva is expecting the U.S. regulator’s decision on the tardive dyskinesia indication by August.