April 12, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Neurocrine Biosciences , headquartered in San Diego, announced that its Ingrezza (valbenazine) had been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with tardive dyskinesia (TD).
Tardive Dyskinesia is marked by uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face. TD often results as a side effect of antipsychotics and other drugs for schizophrenia, bipolar disorder and depression. These drugs block dopamine receptors in the brain, and TD is believed to come from irregular dopamine signaling in the part of the brain that controls movement. Symptoms can be severe and are often permanent.
Ingrezza is a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor. It is the first and only treatment for TD approved by the FDA.
“The often debilitating effects of tardive dyskinesia have left people feeling isolated and forgotten,” said Kevin Gorman, Neurocrine’s chief executive officer, in a statement. “The approval of Ingrezza represents a turning point for these patients and their care partners, offering a meaningful treatment where before there was little hope. For the past 20 years, Neurocrine has been devoted to developing treatments for difficult to manage conditions in underserved patient populations. We are committed to ensuring that those impacted by the disruptive effects of TD have access to Ingrezza.”
The drug is expected to hit the market on May 1. Barclays has estimated it could hit $1 billion in peak sales for TD alone. EvaluatePharma has also projected blockbuster status.
The hitch? Potentially, the price. At this point, the company has declined to provide a possible price for the drug. There are a potential 500,000 patients for the drug in the U.S.
John Carroll, writing for Endpoints News, says, “Like a growing number of companies, Neurocrine wants a clean shot at celebrating the approval without having to explain the cost—a sensitive topic with manufacturers and payers.”
The company has indicated that it has created the INBRACE patient support program, which will help patients gain access to the drug. It is accepting treatment initiation forms immediately.
“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,” said Christoph Correll, professor, Psychiatry and Molecular Medicine, at Hofstra Northwell School of Medicine, in a statement. “In clinical trials, Ingrezza significantly and rapidly improved TD symptoms compared to placebo, reducing involuntary movements acutely and through 38 weeks of treatment without compromising underlying psychiatric care. These results, combined with convenient once-daily dosing, represent a tremendous breakthrough for patients suffering from TD.”
The only potential competition at the moment is Teva Pharmaceutical Industry (TEVA)’s Austedo, but it hasn’t been quite as effective in trials as Ingrezza. Austedo has a PDUFA date of August 30.
John Carroll writes, “Investigators for Teva say that a high and mid-range dose of their drug hit the primary endpoint on the movement scale rating for a ‘modified intent to treat’ group in their second late-stage study. The low dose failed to separate significantly from the placebo. But the high dose, meanwhile, missed beating the placebo based on investigators’ assessment of how their patients were doing.”
Not surprisingly, Neurocine took a big jump at the news and is currently trading for $50.70. That’s up from $40.24 on April 6, but still down from a year high of $54.77 on November 14, 2016.
