Neurocrine Eyes June Launch Date For Valbenazine In Tardive Dyskinesia
Company no longer has to worry about a US FDA advisory committee review, which the agency cancelled. Launch preparations include hiring 140 sales reps.
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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.
FDA approved Teva’s Austedo (deutetrabenazine) for chorea associated with Huntington’s disease, with a warning on depression and suicidality similar to generic Xenazine, but other parts of the labeling points to advantages.