FDA grants Biohaven's trigriluzole Fast Track Designation
Biohaven Pharmaceutical announced that the FDA has granted the company Fast Track Designation for Biohaven's product candidate trigriluzole (BHV-4157) for the potential treatment of Spinocerebellar Ataxia (SCA). Trigriluzole previously received Orphan Drug Designation from the FDA for the treatment of SCA in 2016. Biohaven is currently conducting a phase II/III clinical trial in patients with SCA, with topline results expected in 2018.
SCA is a rare, debilitating neurodegenerative disorder that is estimated to affect approximately 22,000 people in the United States. Standard of care treatment is supportive and no medications are currently approved for patients with this debilitating condition.
"This Fast Track Designation from the FDA recognizes the high unmet medical need in patients with SCA," said Vlad Coric, M.D., CEO of Biohaven. "Fast track designation will help facilitate Biohaven's development of trigriluzole, and potentially expedite future regulatory review of trigriluzole for patients with SCA."
Biohaven initiated a randomized clinical trial of trigriluzole in patients with SCA in December 2016. Target enrollment is approximately 120 patients, with topline results expected in the first quarter of 2018. The study is designed to evaluate the safety and efficacy of trigriluzole for acute symptomatic treatment in this patient population. We believe that, if successful, this phase II/III clinical trial will be the only pivotal trial necessary to support regulatory approval in SCA.
"Given the severe nature of this disease and the inadequacy of palliative treatments for patients with SCA we are endeavoring to complete our study as soon as possible," said Robert Berman, M.D., chief medical officer at Biohaven.