Teva's Huntington's Rejection May Be Neurocrine's Good Fortune
Teva Pharmaceutical Industries Ltd.'s bad luck in getting its experimental Huntington's disease drug deutetrabenazine (SD-809) across the FDA's finish line may be Neurocrine Bioscience's good fortune for its investigational agent valbenazine in another indication – tardive dyskinesia, a condition for which both companies are expected to file applications for their respective products in the US.
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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.
Teva, mostly known for being the world's largest generic company and the maker of the multiple sclerosis drug Copaxone (glatiramer acetate injection), has ventured into the rare disease area, pursuing an orphan medicine for Huntington's disease, a fatal neurodegenerative condition that affects about 30,000 Americans.
Teva's investigational drug SD-809 (deutetrabenazine) has hit its endpoint in moderate to severe tardive dyskinesia patients in a pivotal Phase II/III trial, top-line results show. The drug, which Teva acquired when it bought Auspex Pharmaceuticals earlier this year, is one of the leading candidates in this neurological disease, for which there are currently no approved treatments in the US.