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.
Biohaven Returns With Positive RWE Data In Spinocerebellar Ataxia
The company announced data from a real-world evidence study that compared a three-year analysis of existing Phase III data with an external control and plans to file with the FDA in the fourth quarter.
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