Neurocrine Gets First Drug For Tardive Dyskinesia To FDA
Neurocrine submits NDA for its VMAT inhibitor valbenazine for tardive dyskinesia, getting to FDA ahead of Teva, which is developing a similar product, deutetrabenazine, for the same indication.
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A summertime battle is expected between Neurocrine and Teva once both companies get their tardive dyskinesia drugs on the US market, but Neurocrine's April 11 approval for Ingrezza without an FDA warning label is already giving the biotech an edge.
Neurocrine secured FDA approval for the first drug to treat tardive dyskinesia, a large market that crosses multiple diseases and has blockbuster potential.
Company no longer has to worry about a US FDA advisory committee review, which the agency cancelled. Launch preparations include hiring 140 sales reps.