The Food and Drug Administration (FDA) has granted Fast Track designation to trigriluzole (BHV-4157; Biohaven) for the potential treatment of Spinocerebellar Ataxia (SCA), a rare and debilitating neurodegenerative disorder.

Biohaven is currently investigating trigriluzole in a randomized Phase 2/3 clinical trial to evaluate its efficacy and safety for acute symptomatic treatment in patients with SCA. Currently, there are no FDA-approved pharmacologic treatments for this debilitating disorder. Topline results for this study are expected in the first quarter of 2018. 

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Trigiluzole is a novel, first-in-class tripeptide prodrug which previously received FDA’s Orphan Drug designation for the treatment of SCA.

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