Brief

Neurocrine's Ingrezza secures FDA approval

Dive Brief:

  • Neurocrine Biosciences will soon have its first marketed product now that the Food and Drug Administration has approved the company's lead candidate for movement disorders.
  • Ingrezza (valbenazine) got a green light Tuesday as a treatment for adults with tardive dyskinesia (TD), a condition stemming from years of antipsychotic drug use. The involuntary muscle motions characteristic of TD, therefore, are seen most often among people with mental illnesses such as schizophrenia or depression who were prescribed those drugs.
  • The San Diego-based company plans to start distributing Ingrezza next week to a select group of pharmacies, though it did not elaborate further in an April 11 statement. Neurocrine's sales force will begin promoting the drug to prescribers on May 1

Dive Insight:

Shedding the clinical-stage title helped Neurocrine stock take off. Shares were up more than 21% to $50.24 apiece in Wednesday morning trading.

Teva's shares, meanwhile, were down — albeit less than 1%. Neurocrine's success poses a problem for the Israeli drugmaker, which has its own TD treatment waiting in the wings. Austedo (deutetrabenazine), which just gained FDA approval as a treatment for Huntington's disease chorea on April 3, has a PDUFA date of August 30 for the indication.

Both Ingrezza and Austedo are vesicular monoamine transporter 2, or VMAT2, inhibitors. VMAT2 helps to regulate neurotransmitter movement between neurons. When the protein is stifled, it can't release chemicals like dopamine — the improper signaling of which leads to TD, according to research.

Teva's treatment, however, carries a black box warning for depression and suicidality, reinforcing industry followers belief that Ingressa could have the upper hand in the movement disorder space. 

"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 Correll, a professor of psychiatry and molecular medicine at the Hofstra Northwell School of Medicine said in the statement, adding that Ingrezza's clinical results "combined with convenient once-daily dosing, present a tremendous breakthrough for patients suffering from TD."

Tardive dyskinesia affects as many as one in five patients taking anti-psychotics, according to the nonprofit advocacy organization Mental Health America. As context, a study published last year in JAMA Internal Medicine found 17% of responders to the Medical Expenditure Panel Survey, a collection of large-scale healthcare surveys, filled at least one prescription for some form of antipsychotic drug in 2013. Of those taking the drugs, 80% reported long-term use.

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Filed Under: Clinical Trials Marketing
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