Biohaven Ltd. is hoping it will have better luck this time around as it prepares to apply for US Food and Drug Administration approval of troriluzole in spinocerebellar ataxia (SCA) based on a real-world evidence (RWE) trial after the drug failed in prior studies, resulting in a refuse-to-file (RTF) letter from the agency. However, some analysts have pointed to continued skepticism about its chances despite the company having designed the study in discussion with the FDA.
The New Haven, CT-based biotech announced 23 September topline results from Study BHV4157-206-RWE, which demonstrated the drug’s efficacy on the primary endpoint of change from baseline in the modified functional...
Key Takeaways
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Biohaven announced positive results from a Phase III study of troriluzole in spinocerebellar ataxia that used a real-world evidence-based design based on discussions with the FDA....
