Biohaven receives Fast Track Designation for SCA treatment

Biohaven Pharmaceutical Holding Co. has been granted Fast Track Designation for its product candidate Trigriluzole by the FDA.

Trigriluzole has already been given Orphan Drug Designation from the FDA as a solution for SCA, a neurodegenerative disorder that debilitates and affects roughly 22,000 Americans. 

Biohaven is working on a Phase 2/3 clinical trial for individuals with SCA, in the hopes of securing full approval of Trigriluzole. Currently, no medications are approved for the treatment of SCA. The results of the trial are anticipated in 2018.

"Fast track designation will help facilitate Biohaven's development of trigriluzole, and potentially expedite future regulatory review of trigriluzole for patients with SCA," Biohaven CEO Vlad Coric said.

The clinical trial will ideally have 120 patients enrolled and will seek establish the medication as a safe and effective treatment for SCA.