US FDA approves Neurocrine Biosciences’ first commercial product, a treatment for tardive dyskinesia

The headquarters of the U.S. Food and Drug Administration (FDA) is seen in Silver Spring, Maryland November 4, 2009. Reuters/Jason Reed

Neurocrine Biosciences Inc. announced that its drug obtained approval from the US Food and Drug Administration to be used for the treatment of tardive dyskinesia. Its shares are now up about 18.5 percent to US$ 49.15 (AU$65.59) since Tuesday.

Ingrezza, Neurocrine Biosciences’ first commercial product, had become the first treatment to be approved by the US FDA for tardive dyskinesia, a side effect of antipsychotic medications by uncontrolled movements of the body. Five to eight percent of patients taking antipsychotic drugs deal with the irreversible disorder.

According to the company, the drug is expected to be launched in May with a competitive price. Neurocrine said the drug would be listed at a net price of between US$20,000 (AU$26,000) to US$60,000 (AU$80,000) and the amount will depend on the required dosage.

Ingrezza, also known as valbenazin, intends to block a protein found in the brain that aides regulate the amount of dopamine released into nerve cells. Neurocrine Biosciences Chief Executive Officer Kevin Gorman said at least 500,000 Americans suffer from tardive dyskinesia. He estimated that at least 100,000 would be treated with Ingrezza.

Gorman explained that the effects of the disorder caused people to feel they were forgotten, adding that the okay from the US FDA is a turning point for these patients, as well as their care partners. Neurocrine Biosciences has been developing treatments for the past 20 years and Gorman assured that it would guarantee that people who are dealing with the disruptive effects of tardive dyskinesia will get access to the treatment.

Christoph U. Correll, MD, Professor, Psychiatry and Molecular Medicine at Hofstra Northwell School of Medicine, shared that one of the few options for physicians when dealing with the disorder is stopping, changing or lowering the dose of antipsychotic medication. He recognised that Ingrezza had helped improve tardive dyskinesia during clinical trials as it reduced involuntary movements acutely and through 48 weeks of treatment without the need to compromise underlying psychiatric care. Street Insider noted that clinical studies have shown that Ingrezza provides improvement in signs and symptoms associated with the disorder compared to placebo through six weeks.

Paul Gionfriddo, President & CEO of Mental Health America, said a treatment for tardive dyskinesia is perceived as a welcome step in the continued effort to destigmatize mental health conditions. He said doctors and individuals can now have more productive and proactive conversations regarding the disorder. Ingrezza’s promotion to healthcare professionals will start on May 1.