Biohaven Ltd. (BHVN) announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) seeking approval of VYGLXIA (troriluzole) for the treatment of spinocerebellar ataxia (SCA).
The company noted that the CRL was issued despite Study 206-RWE being reviewed by the FDA and achieving statistical significance in its prespecified primary and secondary efficacy endpoints. The FDA cited concerns commonly associated with real-world evidence and external control studies, including potential bias, design flaws, lack of pre-specification, and unmeasured confounding factors.
Biohaven said it remains committed to working with the FDA to find a path forward for its NDA for VYGLXIA and plans to meet with the FDA to discuss potential next steps.
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