Biohaven Announces Orphan Drug Designation Request Granted for the Treatment of Spinocerebellar Ataxia

Biohaven Pharmaceutical Holding Company Ltd. announced that the Food and Drug Administration has granted the company’s orphan drug designation request covering BHV-0223 for the treatment of spinocerebellar ataxia.
According to the news:

BHV-0223 is a unique formulation of riluzole, a glutamate modulating agent, that utilizes the Zydis® ODT fast-dissolve technology under an exclusive worldwide agreement with Catalent. Agents that modulate glutamate neurotransmission may have therapeutic potential in multiple disease states involving glutamate dysfunction, including ALS, Alzheimer’s disease, Rett syndrome, dementia, dystonia, tinnitus, anxiety disorders, and affective disorders like major depressive disorder. Biohaven is pursuing the use of glutamate modulating agents across several therapeutic indications.

Robert Berman, M.D., CMO of Biohaven commented:

Modulation of cerebellar glutamate has potential for efficacy in populations with spinocerebellar ataxias, Biohaven sees an opportunity to leverage its glutamate targeting drug platform to address this important debilitating illness.

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