Portage Biotech announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to Biohaven’s investigational agent BHV-4157 for the treatment of Spinocerebellar Ataxia (SCA).
Spinocerebellar ataxia, a rare, debilitating neurodegenerative disorder, currently has no approved pharmacological treatment, only supportive therapy.
Biohaven intends to initiate a randomized clinical trial for BHV-4157 in 120 patients with hereditary SCA before the end of 2016. Results from this trial are expected to support a New Drug Application (NDA) for BHV-4157 in SCA.
BHV-4157 is a novel glutamate-modulating agent.