Biohaven's trigriluzole receives fast track designation from U.S. FDA

Biohaven Pharmaceutical

15 May 2017 - Potential first-in-class therapy for spinocerebellar ataxia.

Biohaven Pharmaceutical announced today that the U.S. 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 2/3 clinical trial in patients with SCA, with topline results expected in 2018.

Read Biohaven Pharmaceutical press release

Michael Wonder

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Michael Wonder

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Medicine , US , Submission , Fast track