FDA extends PDUFA for Biohaven’s Troriluzole new drug application

The company states: “Biohaven (BHVN) announced that the Division of Neurology 1 within FDA’s Office of Neuroscience informed the Company that they are extending the PDUFA date for the troriluzole new drug application for the treatment of spinocerebellar ataxia, SCA, by three months to provide time for a full review of Biohaven’s recent submissions related to information requests from the FDA. The Division also informed Biohaven that it is currently planning to hold an advisory committee meeting to discuss the application, but no date has been scheduled. The FDA did not raise any new concerns in the letter. The FDA’s decision regarding the NDA is now expected in 4Q 2025. Biohaven previously received Fast-Track, Orphan Drug Designation and Priority Review from the FDA regarding troriluzole for SCA. Priority Review designation is assigned to applications for drugs that would offer a significant improvement over other available treatments for a given disorder or would provide a treatment option where none exists. In the case of SCA, a rare, genetic, neurodegenerative disease, troriluzole would be the first and only FDA-approved treatment for this life-threatening disorder.”