Kevin Gorman, CEO of Neurocrine Biosciences, presents at a Jefferies investor conference in 2013. Bloomberg/via Getty Images
The FDA has followed through with an approval for Neurocrine Bioscience’s Ingrezza (valbenazine) for tardive dyskinesia, setting up a potential showdown just a week after Teva scored with their rival therapy, now approved for Huntington’s chorea.
Unlike Teva, Neurocrine’s label has come through without a black box warning on depression and suicidal ideation, giving it a distinct edge in any marketing confrontation to come as Teva waits for the FDA to decide on its own application to hit the TD market. Neurocrine shares jumped 28% on the news, though some analysts had fretted about the label.
The approval marks a sea change for San Diego-based Neurocrine $NBIX, which has been building up a sales force for its first commercial launch. Analysts next want to see late-stage Tourette syndrome data on Ingrezza and NDAs for elagolix — partnered with AbbVie — in endometriosis and uterine fibroids as the biotech journeys through a transformative year.
Barclays, for one, has offered Neurocrine’s drug its stamp of blockbuster-worthiness, estimating peak sales at more than $1 billion for tardive dyskinesia alone. EvaluatePharma has also tracked a blockbuster future for this drug as well, designed to treat involuntary movements spurred by the prolonged use of antipsychotics. Huntington’s chorea is a related condition involving involuntary twisting and writhing.
“This is a momentous occasion for us,” said CEO Kevin Gorman in a Tuesday evening call with analysts. Few companies can say they discovered a drug in their lab, developed it and grabbed an FDA approval, he added. This is the first drug approved for TD.
What Gorman and his team didn’t say, though, was how much the drug will cost. 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. That will come with the launch, slated for May 1.
The latest approval came through after Neurocrine published the full set of data in its favor, including a note that its drug scored for 40% of the patients in the drug arm who registered at least a 50% improvement in the AIMS dyskinesia score, compared to 8.7% of those on placebo.
“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 U. Correll, MD, Professor, Psychiatry and Molecular Medicine, Hofstra Northwell School of Medicine. “In clinical trials, INGREZZA significantly and rapidly improved TD symptoms compared to placebo, reducing involuntary movements acutely and through 48 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.”
Last fall Teva incited a considerable amount of speculation about how it could one day rival Neurocrine in tardive dyskinesia with Austedo (SD-809, deutetrabenazine). But their mixed results also sparked more than a little kickback from analysts who prefer Ingrezza. The FDA handed Teva’s drug — acquired 2 years ago in a $3.5 billion Auspex buyout — a priority review for TD in February and assigning them an August 30 PDUFA date.
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.
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