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Company received a Complete Response Letter from the agency.
Biohaven Ltd. (NYSE: BHVN) disclosed that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the company's new drug application (NDA) resubmission for Vyglxia (troriluzole) intended for the treatment of spinocerebellar ataxia (SCA). The FDA cited deficiencies that must be addressed before the application can be approved.
The notification came as a Complete Response Letter, a formal communication from the FDA outlining the specific deficiencies in the NDA resubmission. Biohaven must now work to resolve these issues to potentially gain approval for Vyglxia in the indicated use.
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